AMPLATZER Cardiac Plug Clinical Trial | NCT01118299

Status Module

Label	Type	Description	Intervention Names
Device	Experimental	AMPLATZER Cardiac Plug	Device: AMPLATZER Cardiac Plug
Optimal Medical Therapy (control)	Active Comparator	Warfarin Dabigatran	Device: AMPLATZER Cardiac Plug

Name	Type	Description	Arm Group Labels	Other Names
AMPLATZER Cardiac Plug	Device	AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Device Optimal Medical Therapy (control)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only	An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol.	From Randomization to Discharge Visit
Long-term Safety - Device Arm Only	All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.	Randomization to 2 year follow-up
Effectiveness Endpoint - Device Arm Only	Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Good Samaritan Hospital		Los Angeles	California	90017	United States
Cedars-Sinai Medical Center

Label	URL
What is Atrial Fibrillation - Fact Sheet	View source
Overview of Atrial Fibrillation	View source
Let's Talk about Stroke, TIA and Warning Signs - Fact Sheet

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Device	AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
FG001	Optimal Medical Therapy (Control)	Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 23, 2014

ID	Title	Description
BG000	Device	AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
BG001	Optimal Medical Therapy (Control)	Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00068 BG00129 BG00297

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

Device Embolization

Title	Measurements
	OG0003

Pleural Effusion

Title	Measurements
	OG0001

Hematoma

Primary

Long-term Safety - Device Arm Only

All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).

However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.

No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm.

Posted

Number

Events

Randomization to 2 year follow-up

ID	Title	Description
OG000	Device Arm	Subjects who received the ACP device

Units	Counts
Participants	OG000

Primary

Effectiveness Endpoint - Device Arm Only

Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT).

However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol.

No data were collected for the Control Arm/Group due to early enrollment closure and the pre-specified analysis was revised accordingly to report data for only the Device Arm.

Posted

Number

events

Randomization through 2 year follow up

ID	Title	Description
OG000	Device Arm	Subjects who received the ACP device

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abnormal Coagulation Parameter	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Abnormal Lab Value	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Acute Bronchitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Acute Erosive Gastritis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Acute Pancreatitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Acute Renal Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Angina Pectoris	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Arthritis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG00010 events8 affected68 at risk EG0011 events1 affected29 at risk
Atrial Flutter	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Atrial Tachycardia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected29 at risk
Bacteremia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Bacterial Infections	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Benign Tumors	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Breast Cancer	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Cancer	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Cardiac Arrest	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cardiac Perforation*	Cardiac disorders	Company's AE Coding	Systematic Assessment	* This event was considered as sub-event of the master event for Pericardial Tamponade.	EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cardiogenic Shock*	Cardiac disorders	Company's AE Coding	Systematic Assessment	* This event was considered as sub-event of the master event for Pericardial Tamponade.	EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cellulitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Cerebral Aneurysm	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cervical Stenosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Chest Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0010 events0 affected29 at risk
Cholecystitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Chronic Obstructive Pulmonary Disease (COPD)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0006 events2 affected68 at risk EG0011 events1 affected29 at risk
Closed Head Injury	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Colitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Confusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Congestive Heart Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0006 events5 affected68 at risk EG0017 events6 affected29 at risk
Constrictive Pericarditis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Coronary Artery Disease	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Deep Vein/Venous Thrombosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Dehydration	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Delirium	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Device Closure of ASD	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Device Embolization	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0010 events0 affected29 at risk
Drug Side Effect	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected29 at risk
Dysphagia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Dyspnea	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Ear Infection	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Elective Procedure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Elective Surgery	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0012 events2 affected29 at risk
Emphysema	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Empyema	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Encephalopathy	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Esophageal Laceration and Rupture	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Fall	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Fracture	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Gout	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Heart Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hemarthrosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events1 affected68 at risk EG0010 events0 affected29 at risk
Hematoma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Hemorrhagic Stroke	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hemothorax	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hip Fracture	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Hydrocephalus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Hypertensive Crisis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hyponatremia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hypotension	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Ischemic Stroke	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0012 events2 affected29 at risk
Knee Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Low Back Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Lumbar Disc Displacement	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Lumbar Spondylosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Melena	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Migraine	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Mononucleosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Myocardial Infarction	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Osteoarthritis/Degenerative Joint Disease	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Other: Pancreatic pseudocyst	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Paroxysmal Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Pericardial Effusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events5 affected68 at risk EG0010 events0 affected29 at risk
Pericardial Tamponade	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0010 events0 affected29 at risk
Pericarditis*	Cardiac disorders	Company's AE Coding	Systematic Assessment	* This event was considered as sub-event of the master event for Pericardial Tamponade.	EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Peripheral Arterial Occlusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Persistent Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0006 events3 affected68 at risk EG0010 events0 affected29 at risk
Pleural Effusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Pneumonia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0008 events4 affected68 at risk EG0012 events2 affected29 at risk
Polyneuropathy	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Presyncope	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pulmonary Embolism	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Renal Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Renal Insufficiency	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Respiratory Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events3 affected68 at risk EG0010 events0 affected29 at risk
Sepsis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events3 affected68 at risk EG0012 events2 affected29 at risk
Sick Sinus Syndrome	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0012 events2 affected29 at risk
Sinusitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Spells	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Spinal Stenosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Stroke	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Syncope	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Transient Ischemic Attack (TIA)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Trauma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Unstable Angina	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events1 affected68 at risk EG0010 events0 affected29 at risk
VASC Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
VASC Hematoma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Vancomycin-Resistant Enterococcus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Ventricular Tachycardia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Viral Gastroenteritis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Visual Disturbance	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal Bloating	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Abdominal Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Abnormal Coagulation Parameter	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events1 affected68 at risk EG0011 events1 affected29 at risk
Abnormal Lab Value	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Abnormal Renal Function	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Abrasion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Acute Bronchitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0011 events1 affected29 at risk
Acute Kidney Injury	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Acute Renal Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected29 at risk
Air Embolus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Allergic Drug Reaction	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Allergy	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Anemias	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Animal Bite	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Anxiety	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Anxiety Reaction	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Aortic Aneurysms	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected29 at risk
Aortic Valve Stranding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Aphasia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Arm Fracture	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Arterial Hypertension/Hypertension	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Arthritis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Asthma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Asymptomatic Ischemic Stroke	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Atelectasis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0009 events6 affected68 at risk EG0011 events1 affected29 at risk
Atrial Flutter	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected29 at risk
Back Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Bee Sting	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Behavior Alterations	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Bells Palsy	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events5 affected68 at risk EG0010 events0 affected29 at risk
Bronchitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Bruise/Purpura Simplex	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0006 events5 affected68 at risk EG0011 events1 affected29 at risk
Bursitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Carpal Tunnel	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cataract	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Cellulitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Chest Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0013 events2 affected29 at risk
Chronic Obstructive Pulmonary Disease (COPD)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Chronic Renal Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Chronic Subdural Hematoma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Colitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Colon Polyps	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Common Cold/Upper Respiratory Tract Infection	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0010 events0 affected29 at risk
Compressive Effect On Nerve	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Concussion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Congestive Heart Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Constipation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Contusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Cough	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Decreased Appetite	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Decreased Sphincter Tone	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Dehydration	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events1 affected68 at risk EG0010 events0 affected29 at risk
Depression	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0011 events1 affected29 at risk
Device Malposition or Malfunction	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Diarrhea	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Diastolic Dysfunction	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Difficulty Catching Breath	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Diplopia/Double Vision	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Diverticulitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Dizziness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events3 affected68 at risk EG0010 events0 affected29 at risk
Drug Rash	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Drug Side Effect	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0011 events1 affected29 at risk
Dyspepsia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Dysphagia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Dyspnea	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0007 events7 affected68 at risk EG0011 events1 affected29 at risk
Earache	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Edema	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0009 events9 affected68 at risk EG0012 events2 affected29 at risk
Elective Procedure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Elective Surgery	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Emesis/Vomiting	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Encephalopathy	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Epididymitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Epistaxis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0012 events2 affected29 at risk
Erectile Dysfunction Symptoms	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Eye Swelling	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Fall	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0007 events6 affected68 at risk EG0012 events2 affected29 at risk
Fatigue/Generalized Fatigue	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
Fever	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Folliculitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Fracture	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0011 events1 affected29 at risk
Fungal Skin Infection	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Gastritis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Gastrointestinal Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Gastrointestinal Illness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Gingival Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Gout	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Headache	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Heart Failure	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Heartburn	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Hemarthrosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Hematoma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Hematuria	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Hemoptysis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hepatic and Biliary Disorders	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hip Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Hyperkalemia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Hypernatremia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hypokalemia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Hypotension	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0008 events8 affected68 at risk EG0010 events0 affected29 at risk
Hypoxemia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Incidental Finding of Stroke	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Intracerebral Haemorrhage	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Iron-Deficiency Anemia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Junctional Escape Rhythm/Intermittent Junctional Rhythm	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Knee Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Lacerations	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Lightheadedness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Low Back Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Lung Crackles	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Memory Difficulty	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Microhemorrhage	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Mitral Valve Regurgitation/Mitral Insufficiency	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Musculoskeletal Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0012 events2 affected29 at risk
Nausea	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Neck Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Nephrolithiasis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Nocturia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Non-Specific EKG Change	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Numbness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events5 affected68 at risk EG0010 events0 affected29 at risk
Onychomycosis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Overhydration	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events3 affected68 at risk EG0011 events1 affected29 at risk
Palpitations	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events5 affected68 at risk EG0012 events2 affected29 at risk
Parkinson's Disease	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Paroxysmal Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Pericardial Effusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0005 events5 affected68 at risk EG0010 events0 affected29 at risk
Peripheral Venous Thrombus	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Persistent Atrial Fibrillation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Phlebitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Plantar Fasciitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pleural Effusion	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events2 affected68 at risk EG0011 events1 affected29 at risk
Pleuretic Pain	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pneumonia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events3 affected68 at risk EG0013 events3 affected29 at risk
Pneumothorax	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Post-Menopausal Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pressure Sores	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events2 affected29 at risk
Psychogenic Event	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Pulmonary Hypertension	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Ramsay Hunt Syndrome	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Rash	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Residual Interatrial Communication	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0007 events7 affected68 at risk EG0010 events0 affected29 at risk
Respiratory Illness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Rhinitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
ST Segment Changes	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Sciatica	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Shingles	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0004 events4 affected68 at risk EG0010 events0 affected29 at risk
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Sinusitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events2 affected68 at risk EG0010 events0 affected29 at risk
Skin Cancer	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Skin Lesions	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Skin Ulcer	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Sore Throat	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0006 events5 affected68 at risk EG0010 events0 affected29 at risk
Spells	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events1 affected68 at risk EG0012 events2 affected29 at risk
Stupor	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Syncope	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Tachycardia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Temporomandibular Joint	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Tendosynovitis	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Thrombocytopenia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Thrombus on Device	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Thyroid Disorders	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Toe Inflammation	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Transient Imbalance	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Transient Ischemic Attack (TIA)	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0012 events1 affected29 at risk
Trauma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Tremor	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Uncontrolled Blood Sugar	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia	Cardiac disorders	Company's AE Coding	Systematic Assessment	Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia: Other - Non-sustained runs of VT, Ventricular Ectopic Beats/Premature Ventricular Contractions/Premature Ventricular Beats	EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Urinary Incontinence	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0000 events0 affected68 at risk EG0011 events1 affected29 at risk
Urinary Retention	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0011 events1 affected29 at risk
Urinary Tract Infections	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0007 events6 affected68 at risk EG0011 events1 affected29 at risk
VASC Bleeding	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG00010 events10 affected68 at risk EG0010 events0 affected29 at risk
VASC Bruise	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0003 events3 affected68 at risk EG0010 events0 affected29 at risk
VASC Hematoma	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0007 events7 affected68 at risk EG0010 events0 affected29 at risk
VASC Pseudoaneurysm	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk
Ventricular Tachycardia	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Vertigo	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0002 events2 affected68 at risk EG0010 events0 affected29 at risk
Visual Disturbance	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0011 events1 affected29 at risk
Weakness	Cardiac disorders	Company's AE Coding	Systematic Assessment		EG0001 events1 affected68 at risk EG0010 events0 affected29 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Device	AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	7	68	52	68	61	68
EG001	Optimal Medical Therapy (Control)	Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	5	29	15	29	15	29

ID	Term
D001281	Atrial Fibrillation
D000083242	Ischemic Stroke
D020521	Stroke