Trial Outcomes & Findings for AMPLATZER Cardiac Plug Clinical Trial (NCT NCT01118299)

NCT ID: NCT01118299

Last Updated: 2020-04-14

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: From Randomization to Discharge Visit
• Results posted on: 2020-04-14

Participant Flow

Participant milestones

Measure	Device AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Optimal Medical Therapy (Control) Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Overall Study STARTED	68	29
Overall Study COMPLETED	45	0
Overall Study NOT COMPLETED	23	29

Reasons for withdrawal

Measure	Device AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Optimal Medical Therapy (Control) Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Overall Study Death	7	5
Overall Study Withdrawal by Subject	8	8
Overall Study Lost to Follow-up	2	1
Overall Study Enrollment Closure, Protocol Amendment	6	15

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Device n=68 Participants AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Optimal Medical Therapy (Control) n=29 Participants Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Total n=97 Participants Total of all reporting groups
Age, Continuous	74.0 Years STANDARD_DEVIATION 8.5 • n=68 Participants	73.4 Years STANDARD_DEVIATION 10.0 • n=29 Participants	73.5 Years STANDARD_DEVIATION 8.9 • n=97 Participants
Sex: Female, Male Female	23 Participants n=68 Participants	11 Participants n=29 Participants	34 Participants n=97 Participants
Sex: Female, Male Male	45 Participants n=68 Participants	18 Participants n=29 Participants	63 Participants n=97 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
CHADS2 Score Chads2 Score 0	0 Participants n=68 Participants	0 Participants n=29 Participants	0 Participants n=97 Participants
CHADS2 Score Chads2 Score 1	0 Participants n=68 Participants	0 Participants n=29 Participants	0 Participants n=97 Participants
CHADS2 Score Chads2 Score 2	38 Participants n=68 Participants	17 Participants n=29 Participants	55 Participants n=97 Participants
CHADS2 Score Chads2 Score 3	20 Participants n=68 Participants	7 Participants n=29 Participants	27 Participants n=97 Participants
CHADS2 Score Chads2 Score 4	7 Participants n=68 Participants	4 Participants n=29 Participants	11 Participants n=97 Participants
CHADS2 Score Chads2 Score 5	2 Participants n=68 Participants	1 Participants n=29 Participants	3 Participants n=97 Participants
CHADS2 Score Chads2 Score 6	1 Participants n=68 Participants	0 Participants n=29 Participants	1 Participants n=97 Participants
History of Atrial Fibrillation Paroxysmal	32 Participants n=68 Participants	19 Participants n=29 Participants	51 Participants n=97 Participants
History of Atrial Fibrillation Persistent	21 Participants n=68 Participants	7 Participants n=29 Participants	28 Participants n=97 Participants
History of Atrial Fibrillation Permanent	15 Participants n=68 Participants	3 Participants n=29 Participants	18 Participants n=97 Participants
Rhythm Status at Baseline Paced Rhythm	17 Participants n=67 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	15 Participants n=29 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	32 Participants n=96 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.
Rhythm Status at Baseline Atrial Fibrillation	29 Participants n=67 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	5 Participants n=29 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	34 Participants n=96 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.
Rhythm Status at Baseline Sinus Rhythm	19 Participants n=67 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	7 Participants n=29 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	26 Participants n=96 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.
Rhythm Status at Baseline Other Arrhythmias or Conduction Disturbance	2 Participants n=67 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	2 Participants n=29 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.	4 Participants n=96 Participants • One subject did not have a baseline ECG performed. Hence the denominator is for 96 subjects.

PRIMARY outcome

Timeframe: From Randomization to Discharge Visit

Population: 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.

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.

Outcome measures

Measure	Device Arm n=68 Participants Subjects who received the ACP device
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Device Embolization	3 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Pleural Effusion	1 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Hematoma	1 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Pericardial Tamponade	3 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Cardiac Perforation*	1 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Pericardial Effusion	1 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Cardiogenic Shock*	1 events
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only Pericarditis*	1 events

PRIMARY outcome

Timeframe: Randomization to 2 year follow-up

Population: 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.

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.

Outcome measures

Measure	Device Arm n=68 Participants Subjects who received the ACP device
Long-term Safety - Device Arm Only Empyema (Major Bleeding)	1 Events
Long-term Safety - Device Arm Only Hemothorax (Major Bleeding)	1 Events
Long-term Safety - Device Arm Only Hematoma (Major Bleeidng)	1 Events
Long-term Safety - Device Arm Only Bleeding (Major Bleeding)	1 Events
Long-term Safety - Device Arm Only Respiratory Failure (Death)	2 Events
Long-term Safety - Device Arm Only Congestive Heart Failure (Death)	1 Events
Long-term Safety - Device Arm Only Device Embolization (Death)	1 Events

PRIMARY outcome

Timeframe: Randomization through 2 year follow up

Population: 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.

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.

Outcome measures

Measure	Device Arm n=68 Participants Subjects who received the ACP device
Effectiveness Endpoint - Device Arm Only Ischemic Stroke	2 events
Effectiveness Endpoint - Device Arm Only Peripheral Thromboembolism	0 events

Adverse Events

Device

Serious events: 52 serious events

Other events: 61 other events

Deaths: 7 deaths

Optimal Medical Therapy (Control)

Serious events: 15 serious events

Other events: 15 other events

Deaths: 5 deaths

Serious adverse events

Measure	Device n=68 participants at risk AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Optimal Medical Therapy (Control) n=29 participants at risk Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Cardiac disorders Deep Vein/Venous Thrombosis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dehydration	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Delirium	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Device Closure of ASD	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Device Embolization	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Drug Side Effect	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dysphagia	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dyspnea	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Ear Infection	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Elective Procedure	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Elective Surgery	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Emphysema	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Empyema	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Encephalopathy	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Esophageal Laceration and Rupture	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fall	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fracture	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gout	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Heart Failure	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hemarthrosis	1.5% 1/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hematoma	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hemorrhagic Stroke	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hemothorax	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hip Fracture	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hydrocephalus	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hypertensive Crisis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hyponatremia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hypotension	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Ischemic Stroke	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Knee Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Low Back Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Lumbar Disc Displacement	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Lumbar Spondylosis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Melena	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Migraine	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abnormal Coagulation Parameter	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abnormal Lab Value	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Bronchitis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Erosive Gastritis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Pancreatitis	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Renal Failure	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Angina Pectoris	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Arthritis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atrial Fibrillation	11.8% 8/68 • Number of events 10 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atrial Flutter	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atrial Tachycardia	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bacteremia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bacterial Infections	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Benign Tumors	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bleeding	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Breast Cancer	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cancer	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cardiac Arrest	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cardiac Perforation*	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cardiogenic Shock*	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cellulitis	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cerebral Aneurysm	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cervical Stenosis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chest Pain	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cholecystitis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chronic Obstructive Pulmonary Disease (COPD)	2.9% 2/68 • Number of events 6 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Closed Head Injury	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Colitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Confusion	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Congestive Heart Failure	7.4% 5/68 • Number of events 6 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	20.7% 6/29 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Constrictive Pericarditis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Coronary Artery Disease	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Mononucleosis	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Myocardial Infarction	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Osteoarthritis/Degenerative Joint Disease	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Other: Pancreatic pseudocyst	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Paroxysmal Atrial Fibrillation	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pericardial Effusion	7.4% 5/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pericardial Tamponade	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pericarditis*	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Peripheral Arterial Occlusion	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Persistent Atrial Fibrillation	4.4% 3/68 • Number of events 6 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pleural Effusion	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pneumonia	5.9% 4/68 • Number of events 8 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Polyneuropathy	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Presyncope	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pulmonary Embolism	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Renal Failure	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Renal Insufficiency	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Respiratory Failure	4.4% 3/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sepsis	4.4% 3/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sick Sinus Syndrome	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sinusitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Spells	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Spinal Stenosis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Stroke	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Syncope	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Transient Ischemic Attack (TIA)	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Trauma	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Unstable Angina	1.5% 1/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Bleeding	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Hematoma	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Vancomycin-Resistant Enterococcus	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Ventricular Tachycardia	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Viral Gastroenteritis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Visual Disturbance	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.

Other adverse events

Measure	Device n=68 participants at risk AMPLATZER Cardiac Plug AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device	Optimal Medical Therapy (Control) n=29 participants at risk Warfarin Dabigatran AMPLATZER Cardiac Plug: AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Cardiac disorders Hypernatremia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hypokalemia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Heartburn	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hemarthrosis	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hematoma	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hematuria	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hemoptysis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hepatic and Biliary Disorders	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hip Pain	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hyperkalemia	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abdominal Bloating	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abdominal Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abnormal Coagulation Parameter	1.5% 1/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abnormal Lab Value	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abnormal Renal Function	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Abrasion	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Bronchitis	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Kidney Injury	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Acute Renal Failure	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Air Embolus	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Allergic Drug Reaction	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Allergy	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Anemias	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Animal Bite	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Anxiety	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Anxiety Reaction	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Aortic Aneurysms	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Aortic Valve Stranding	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Aphasia	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Arm Fracture	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Arterial Hypertension/Hypertension	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Arthritis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Asthma	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Asymptomatic Ischemic Stroke	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atelectasis	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atrial Fibrillation	8.8% 6/68 • Number of events 9 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Atrial Flutter	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Back Pain	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bee Sting	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Behavior Alterations	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bells Palsy	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bleeding	7.4% 5/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bronchitis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bruise/Purpura Simplex	7.4% 5/68 • Number of events 6 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Bursitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Carpal Tunnel	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cataract	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cellulitis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chest Pain	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chronic Obstructive Pulmonary Disease (COPD)	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chronic Renal Failure	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Chronic Subdural Hematoma	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Colitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Colon Polyps	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Common Cold/Upper Respiratory Tract Infection	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Compressive Effect On Nerve	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Concussion	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Congestive Heart Failure	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Constipation	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Contusion	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Cough	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Decreased Appetite	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Decreased Sphincter Tone	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dehydration	1.5% 1/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Depression	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Device Malposition or Malfunction	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Diarrhea	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Diastolic Dysfunction	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Difficulty Catching Breath	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Diplopia/Double Vision	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Diverticulitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dizziness	4.4% 3/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Drug Rash	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Drug Side Effect	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dyspepsia	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dysphagia	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Dyspnea	10.3% 7/68 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Earache	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Edema	13.2% 9/68 • Number of events 9 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Elective Procedure	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Elective Surgery	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Emesis/Vomiting	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Encephalopathy	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Epididymitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Epistaxis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Erectile Dysfunction Symptoms	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Eye Swelling	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fall	8.8% 6/68 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fatigue/Generalized Fatigue	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fever	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Folliculitis	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fracture	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Fungal Skin Infection	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gastritis	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gastrointestinal Bleeding	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gastrointestinal Illness	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gingival Bleeding	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Gout	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Headache	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Heart Failure	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hypotension	11.8% 8/68 • Number of events 8 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Hypoxemia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Incidental Finding of Stroke	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Intracerebral Haemorrhage	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Iron-Deficiency Anemia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Junctional Escape Rhythm/Intermittent Junctional Rhythm	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Knee Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Lacerations	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Lightheadedness	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Low Back Pain	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Lung Crackles	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Memory Difficulty	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Microhemorrhage	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Mitral Valve Regurgitation/Mitral Insufficiency	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Musculoskeletal Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Nausea	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Neck Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Nephrolithiasis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Nocturia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Non-Specific EKG Change	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Numbness	7.4% 5/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Onychomycosis	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Overhydration	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pain	4.4% 3/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Palpitations	7.4% 5/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Parkinson's Disease	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Paroxysmal Atrial Fibrillation	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pericardial Effusion	7.4% 5/68 • Number of events 5 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Peripheral Venous Thrombus	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Persistent Atrial Fibrillation	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Phlebitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Plantar Fasciitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pleural Effusion	2.9% 2/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pleuretic Pain	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pneumonia	4.4% 3/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	10.3% 3/29 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pneumothorax	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Post-Menopausal Bleeding	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pressure Sores	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Psychogenic Event	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Pulmonary Hypertension	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Ramsay Hunt Syndrome	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Rash	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Residual Interatrial Communication	10.3% 7/68 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Respiratory Illness	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Rhinitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders ST Segment Changes	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sciatica	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Shingles	5.9% 4/68 • Number of events 4 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sinusitis	2.9% 2/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Skin Cancer	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Skin Lesions	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Skin Ulcer	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Sore Throat	7.4% 5/68 • Number of events 6 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Spells	1.5% 1/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	6.9% 2/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Stupor	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Syncope	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Tachycardia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Temporomandibular Joint	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Tendosynovitis	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Thrombocytopenia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Thrombus on Device	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Thyroid Disorders	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Toe Inflammation	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Transient Imbalance	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Transient Ischemic Attack (TIA)	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Trauma	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Tremor	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Uncontrolled Blood Sugar	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Urinary Incontinence	0.00% 0/68 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Urinary Retention	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Urinary Tract Infections	8.8% 6/68 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Bleeding	14.7% 10/68 • Number of events 10 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Bruise	4.4% 3/68 • Number of events 3 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Hematoma	10.3% 7/68 • Number of events 7 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders VASC Pseudoaneurysm	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Ventricular Tachycardia	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Vertigo	2.9% 2/68 • Number of events 2 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Visual Disturbance	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	3.4% 1/29 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.
Cardiac disorders Weakness	1.5% 1/68 • Number of events 1 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.	0.00% 0/29 • 5 Years Abbott's internal AE coding system used for these AEs. All AEs coded as Cardiac Disorders.

Additional Information

Sripad Bellary

Abbott

Phone: 408845814

Email: sripad.bellary@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place