Trial Outcomes & Findings for Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial (NCT NCT00465270)

NCT ID: NCT00465270

Last Updated: 2019-02-18

Results Overview

Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 980 participants
• Primary outcome timeframe: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.
• Results posted on: 2019-02-18

Participant Flow

Participant milestones

Measure	Device AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Overall Study STARTED	499	481
Overall Study COMPLETED	395	321
Overall Study NOT COMPLETED	104	160

Reasons for withdrawal

Measure	Device AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Overall Study Death	7	11
Overall Study Withdrawal by Subject	34	78
Overall Study Lost to Follow-up	60	67
Overall Study Investigator request	3	4

Baseline Characteristics

Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

Baseline characteristics by cohort

Measure	Device n=499 Participants AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management n=481 Participants Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole	Total n=980 Participants Total of all reporting groups
Age, Continuous	45.7 years STANDARD_DEVIATION 9.7 • n=5 Participants	46.2 years STANDARD_DEVIATION 10.0 • n=7 Participants	45.9 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	231 Participants n=5 Participants	213 Participants n=7 Participants	444 Participants n=5 Participants
Sex: Female, Male Male	268 Participants n=5 Participants	268 Participants n=7 Participants	536 Participants n=5 Participants

PRIMARY outcome

Timeframe: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.

Population: All primary endpoints that occurred in the trial were recurrent non-fatal ischemic strokes.

Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.

Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.

Outcome measures

Measure	Device n=499 Participants AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management n=481 Participants Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization	9 Participants	16 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Only subjects with complete PFO closure data at 6-months were analyzed.

Outcome measures

Measure	Device n=349 Participants AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group	249 Participants	—

POST_HOC outcome

Timeframe: Long Term Follow-up, median of 5.9 years

Outcome measures

Measure	Device n=499 Participants AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management n=481 Participants Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
Rate of Recurrent Nonfatal Stroke, Post-randomization Death, and Fatal Ischemic Stroke Through Long Term Follow-up	18 Participants	28 Participants

Adverse Events

Device

Serious events: 201 serious events

Other events: 285 other events

Deaths: 7 deaths

Medical Management

Serious events: 173 serious events

Other events: 70 other events

Deaths: 11 deaths

Serious adverse events

Measure	Device n=499 participants at risk AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management n=481 participants at risk Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
General disorders ASD	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Abdominal Pain	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Abnormal Lab Value	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Bacterial Endocarditis (ABE)	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Bronchitis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Erosive Gastritis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Gastroenteritis	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Pancreatitis	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Peritonitis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Pulmonary Edema	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Renal Failure	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Subdural Hematoma	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Alcohol Intoxication	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Allergic Device Reaction	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Allergic Drug Reaction	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Altered Sensorium	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Anemias	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Angina Pectoris	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Ankle Fracture	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Anterior Meniscus Tear	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Anxiety	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Aortic Aneurysms	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Appendicitis	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Arm Fracture	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Arterial Hypertension/Hypertension	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Arthritis	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Asthma	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Fibrillation	1.2% 6/499 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.83% 4/481 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Flutter	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Back Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bacterial Infections	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bacterial Infections of the Skin	0.40% 2/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Benign Mass	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bipolar Disorder	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Birth Defect	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bleeding	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Blood Loss	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bowel Obstruction	0.80% 4/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Brain Abcess	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Brain Tumor	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Breast Cancer	1.2% 6/499 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bronchiolitis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bronchitis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Burns	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Caesarean Section	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cancer	1.0% 5/499 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.5% 7/481 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cardiac Arrest	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cardiac Perforation	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cardiac Thrombus	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cardiomyopathy	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cellulitis	0.40% 2/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.2% 6/481 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cerebral Aneurysm	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cerebral Infarct - Asymptomatic***	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cerebrospinal Fluid (CSF) Leak	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cervical Spondylosis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cervical Stenosis	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chest Pain	3.6% 18/499 • Number of events 19 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	3.1% 15/481 • Number of events 16 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chest Tightness	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chills/Rigors	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cholecystitis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.0% 5/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Choledochal Cysts	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Choledocholithiaisis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cholelithiasis	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chronic Obstructive Airway Disorders	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chronic Obstructive Pulmonary Disease (COPD)	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chronic Pancreatitis	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Closed Head Injury	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Colitis	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Colon Cancer	0.20% 1/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Common Cold/Upper Respiratory Tract Infection	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Compartment Syndrome	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Complex Partial Seizures	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Confusion	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Congestive Heart Failure	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Conversion Reaction	0.40% 2/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Coronary Artery Disease	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cutaneous Abcesses	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Deep Vein/Venous Thrombosis	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dehydration	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Delirium	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Depression	0.40% 2/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.83% 4/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Disc Protrusion	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Diverticulitis	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dizziness	0.40% 2/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Drug Side Effect	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Duodenal Cancer	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dysarthria/Slurred Speech	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dyspnea	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Elective Surgery	5.2% 26/499 • Number of events 32 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	3.5% 17/481 • Number of events 20 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Emesis/Vomiting	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Encephalopathy	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Eye Lacerations	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Failure to Thrive	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Fall	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Fenestrated Atrial Septum	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Fever	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Fracture	0.60% 3/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastritis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastroenteritis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastroesophageal Reflux Disease	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastrointestinal Bleeding	1.2% 6/499 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.83% 4/481 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Generalized Seizures	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Generalized Tonic-Clonic Seizures	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Headache	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hematoma	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hemiparesis/Weakness	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hemorrhagic Stroke	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hepatic and Biliary Disorders	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hernia	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Herniated Disc	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hip Dislocation	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hip Fracture	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hip Pain	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Homicide	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hydrocephalus	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hypercarbia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hypertensive Encephalopathy	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hypoglycemia	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hyponatremia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hysterectomy	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.83% 4/481 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Infective/Bacterial Endocarditis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Inferior Myocardial Infarction	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Inguinal Hernia	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Intracerebral Haemorrhage	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Intraparenchymal Haemorrhage	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Ischemic Eighth Nerve	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Ischemic Stroke	3.6% 18/499 • Number of events 19 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	5.8% 28/481 • Number of events 31 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Knee Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Lacerations	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Leukemias	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Long Q-T	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Low Back Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Lung Cancer	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Melanoma	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Melena	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Menorrhagia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Microcytic Anemia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Migraine	2.4% 12/499 • Number of events 15 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.5% 7/481 • Number of events 9 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Missed Abortion	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Multiple Sclerosis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Musculoskeletal Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Myocardial Infarction	1.2% 6/499 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Nausea	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Neck Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Non-Endpoint Transient Ischemic Attack (TIA)	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Numbness	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.83% 4/481 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Obesity	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Orthostatic Hypotension	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Osler Weber Rendu Syndrome	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Osteoarthritis/Degenerative Joint Disease	0.60% 3/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.2% 6/481 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Other - Preterm labor	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Other - SIRS	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Other - Splenic infarcts	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Overdose	0.80% 4/499 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Palpitations	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pancreatic Cancer	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Panic Attack	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Paresthesia/Paraesthesia	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pericardial Effusion	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pericardial Tamponade	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pericarditis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Peripheral Arterial Occlusion	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Peripheral Venous Thrombus	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pleurisy	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pneumonia	1.0% 5/499 • Number of events 9 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.2% 6/481 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pneumonia Caused By Haemophilus Influenzae	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pneumothorax	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Possible Seizure	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pre-eclampsia	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pregnancy	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pregnancy Related Symptoms	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Premature Ventricular Contraction	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Presyncope	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Prostate Discomfort	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pulmonary AVM	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pulmonary Congestion	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pulmonary Embolism	2.4% 12/499 • Number of events 13 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Radiculopathy	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Residual Shunt Requiring Closure	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Respiratory Illness	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Rhabdomyolysis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Right Hepatic Trocar Injury	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Rotator Cuff Tear	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Seizure Disorder	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Seizure/Convulsions/Epilepsy	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sepsis	0.80% 4/499 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Simple Partial Seizures	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Spells	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Spinal Stenosis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Spontaneous Abortion	0.60% 3/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Subarachnoid Haemorrhage	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Subdural Haemorrhage	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Suicide Attempt	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Swelling	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Syncope	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.0% 5/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders TEE-Related Event	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Thyroid Cancer	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Thyroid Disorders	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Thyrotoxicosis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Tingling	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Transient Global Amnesia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Transient Ischemic Attack (TIA)	1.6% 8/499 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	2.3% 11/481 • Number of events 14 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Trauma	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Tubal Ligation	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Uncontrolled Blood Sugar	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Unmasking Old Stroke Symptoms	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Unstable Angina	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Urinary Calculi	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Urinary Incontinence	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Urinary Tract Infections	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Uterine Fibroid	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Uterine Prolapse	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Bleeding	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Hematoma	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Vaginal Child Birth	2.0% 10/499 • Number of events 10 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.0% 5/481 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Vaso Vagal Response	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Vertigo	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Viral Gastroenteritis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Weakness	0.20% 1/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Worsening Vision	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Wound Infection	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.

Other adverse events

Measure	Device n=499 participants at risk AMPLATZER PFO Occluder: patent foramen ovale closure device	Medical Management n=481 participants at risk Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole
General disorders Abdominal Pain	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Abnormal Coagulation Parameter	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Abnormal Lab Value	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Erosive Gastritis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Acute Pulmonary Edema	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Allergic Drug Reaction	1.4% 7/499 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Allergic Dye Reaction	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Anxiety	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Asthma	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atelectasis	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Ectopic Beats/Premature Atrial Beats/Premature Atrial Contractions/Ectopic Atrial Rhythm	2.0% 10/499 • Number of events 10 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Fibrillation	1.4% 7/499 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Flutter	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Atrial Tachycardia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Back Pain	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bleeding	0.80% 4/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.7% 8/481 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Borderline Prolongation of QT Interval	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Bruise/Purpura Simplex	9.2% 46/499 • Number of events 49 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	5.4% 26/481 • Number of events 28 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Buzzing In Chest	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Calf Pain	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cardiac Thrombus	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cellulitis	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chest Pain	9.4% 47/499 • Number of events 48 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chest Tightness	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Chronic Obstructive Pulmonary Disease (COPD)	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Contact Dermatitis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Cough	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Couplet	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Deep Vein/Venous Thrombosis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dental Trauma	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Device Malposition or Malfunction	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Diarrhea	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.62% 3/481 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Difficulty Catching Breath	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dizziness	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Drug Rash	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Drug Side Effect	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.0% 5/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dyspepsia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Dyspnea	1.4% 7/499 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Emesis/Vomiting	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Epistaxis	1.4% 7/499 • Number of events 7 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.2% 6/481 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Esophagitis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Fainting/Blackout	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Flushing	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastritis	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastroenteritis	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastroesophageal Reflux Disease	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastrointestinal Bleeding	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gastrointestinal Illness	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Gingival Bleeding	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Headache	1.6% 8/499 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.7% 8/481 • Number of events 8 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Heartburn	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Heaviness of Legs	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hematochezia	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hematoma	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hematuria	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.42% 2/481 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hemoptysis	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hypotension	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Hypoxemia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Incomplete Right Bundle Branch Block	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Increased Shunt	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Instillation Site Foreign Body Sensation	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Leg Cramps	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Low Back Pain	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Low Hematocrit	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Menorrhagia	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	1.0% 5/481 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Meralgia Paraesthetica	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Mid-Sternal Chest Pressure	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Migraine	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Musculoskeletal Pain	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Nausea	2.2% 11/499 • Number of events 11 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Non-Specific EKG Change	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pain	1.0% 5/499 • Number of events 5 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pain Due to a Catheter Drainage Tube	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Palpitations	8.4% 42/499 • Number of events 44 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Paresthesia/Paraesthesia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Paroxysmal Atrial Fibrillation	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Paroxysmal Supraventricular Tachycardia	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Peptic Ulcer Disease	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pinching Sensation in Chest	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pleural Effusion	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Post-Menopausal Bleeding	0.00% 0/499 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Presyncope	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pruritus/Itching	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Pulmonary Congestion	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Right Axis Deviation	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Right Bundle Branch Block/Complete Right Bundle Branch Block	0.40% 2/499 • Number of events 2 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders ST Segment Changes	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders ST-T Wave Abnormality	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sick Sinus Syndrome	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	3.8% 19/499 • Number of events 20 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sinus Tachycardia	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Sore Throat	0.60% 3/499 • Number of events 3 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders T-Wave Abnormalities	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders TEE-Related Event	2.0% 10/499 • Number of events 10 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Trigeminy	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Unsustained/Nonsustained Ventricular Tachycardia/Cardiac Arrhythmia	0.80% 4/499 • Number of events 4 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Bleeding	3.2% 16/499 • Number of events 16 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Bruise	0.20% 1/499 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Hematoma	7.2% 36/499 • Number of events 36 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders VASC Pain	6.4% 32/499 • Number of events 32 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.00% 0/481 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.
General disorders Vaso Vagal Response	1.2% 6/499 • Number of events 6 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.	0.21% 1/481 • Number of events 1 • The results reported here include adverse events that occurred through the long term follow-up. Patients were followed for a median of 5.9 years.

Additional Information

Dr. Laura O'Brien

Abbott

Email: laura.obrien@abbott.com

Results disclosure agreements

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