Evaluation of VISITAG SURPOINT™ Module With External Proc... | NCT03624881

Label	Type	Description	Intervention Names
VISITAG SURPOINT Module with EPU	Experimental	Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation	Device: Catheter ablation with EPU

Name	Type	Description	Arm Group Labels	Other Names
Catheter ablation with EPU	Device	Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation

Measure	Description	Time Frame
Number of Participants With Primary Adverse Events (PAEs)	A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	Up to 12 months
Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)	Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation [AF], atrial flutter [AFL], and atrial tachycardia [AT]) were reported.	Up to 12 months

Measure	Description	Time Frame
Percentage of Participants With Cumulative PAEs	A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Grandview Medical Center

PubMed Identifier	Type	Citation	Retractions
36137711	Derived	Di Biase L, Monir G, Melby D, Tabereaux P, Natale A, Manyam H, Athill C, Delaughter C, Patel A, Gentlesk P, Liu C, Arkles J, McElderry HT Jr, Osorio J; SURPOINT Postapproval Trial Investigators. Composite Index Tagging for PVI in Paroxysmal AF: A Prospective, Multicenter Postapproval Study. JACC Clin Electrophysiol. 2022 Sep;8(9):1077-1089. doi: 10.1016/j.jacep.2022.06.007. Epub 2022 Aug 31.

ID	Title	Description
FG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 8, 2019	Jun 28, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Primary Adverse Events (PAEs)

A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Units	Counts
Participants	OG000261 OG00148

Title

Denominators

Categories

Title	Measurements
	OG00011 OG0013

Primary

Number of Participants Free From Atrial Tachyarrhythmias (Symptomatic and Asymptomatic)

Number of participants free from symptomatic and asymptomatic atrial tachyarrhythmias (which includes atrial fibrillation [AF], atrial flutter [AFL], and atrial tachycardia [AT]) were reported.

The Per-protocol (PP) set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Percentage of Participants With Cumulative PAEs

A PAE is a serious adverse event, which occurs within the first week (7 days) following an AF ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Number of Participants With Unanticipated Adverse Device Effects (UADEs)

Number of participants with UADEs was reported.

The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Units	Counts
Participants

Secondary

Number of Participants With Serious Non-Primary AEs

Serious non-primary adverse events were defined as serious AEs (SAEs) that are not primary adverse events. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset

Number of participants with bleeding complication by ISTH class and timing of onset were reported. The ISTH classification of major bleeding event is a hemoglobin drop of greater than or equal to (>=) 2 grams per deciliter (g/dL), transfusion of >= 2 units (U) packed red blood cells, symptomatic bleed in a critical area, or fatal bleed. Clinically relevant non-major (CRNM) events require prolong hospitalization or result in laboratory testing, imaging, compression, procedure, interruption of the study medication or a change in concomitant therapy. Minor bleeding events are overt bleeding events that do not meet the criteria for CRNM or major bleeding events.

The safety set consisted of all enrolled participants who had undergone insertion of the STSF or ST catheter and use of the VISITAG SURPOINT module with EPU. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints.

Posted

Count of Participants

Participants

Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 12 Months)

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).

Secondary

Percentage of Participants With Ipsilateral Pulmonary Vein Isolation (PVI) (Entrance Block) at the End of the Procedure

Percentage of participants with ipsilateral PVI (entrance block) at the end of the procedure were reported.

Posted

Number

Percentage of Participants

End of the Procedure (up to 12 months)

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Percentage of Participants With Ipsilateral PVI After First Encirclement Without Acute Reconnection

Percentage of participants with ipsilateral PVI after first encirclement without Acute reconnection was reported.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Units

Secondary

Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins

Percentage of targeted veins with touch-up (ablation of acute reconnection) among all targeted veins was reported.

Posted

Number

Percentage of targeted veins

Up to 12 months

Targeted Veins

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Percentage of Targeted Veins With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement

Percentage of targeted veins with touch-up at anatomical location of acute PV reconnection after first encirclement was reported. The location included anterior, superior, ridge, posterior, and inferior region of the left pulmonary veins (LPV) and right pulmonary veins (RPV).

The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'n' (number of targeted veins analyzed) included all evaluable numbers of targeted veins which were analyzed at specified categories.

Posted

Number

Percentage of targeted veins

Up to 12 months

Targeted Veins

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Number of Participants Who Underwent Repeat Ablation Procedures

Number of participants who underwent repeat ablation procedures were reported.

Posted

Count of Participants

Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Units	Counts

Secondary

Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure

Percentage of participants with PVs re-isolation among all of the targeted PVs at repeat procedure was reported.

The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure

Percentage of participants requiring new linear lesion and/or new foci identified during the repeat ablation procedure was reported.

The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Secondary

Percentage of Participants With 12-Month Single Procedure Success

Percentage of participants with 12-month single procedure success was reported. It is defined as freedom from 1) any repeat procedure for Atrial fibrillation (AF)/Atrial tachycardia (AT)/Atrial flutter (AFL) post index procedure; 2) any class I/III AAD taking during the evaluation period; 3) documented AF/AT/AFL recurrence in evaluation period.

The PP set consisted of all enrolled participants who had undergone RF ablation and were treated with the STSF or ST catheters with the VISITAG SURPOINT Module with EPU, and had been treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure.

Posted

Number

Percentage of Participants

Up to 12 months

ID	Title	Description
OG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
OG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0014 events2 affected49 at risk
Atrial flutter	Cardiac disorders	Non-systematic Assessment	EG00010 events6 affected261 at risk EG0012 events2 affected49 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected0 at risk
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Intracardiac thrombus	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Mitral valve incompetence	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Pericarditis	Cardiac disorders	Non-systematic Assessment	EG0007 events6 affected261 at risk EG0011 events1 affected49 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Duodenal ulcer	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Dysphagia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hiatus hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Umbilical hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Sudden cardiac death	General disorders	Non-systematic Assessment	EG0001 events1 affected261 at risk EG0010 events0 affected49 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG00010 events10 affected261 at risk EG0010 events0 affected49 at risk
Sepsis	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Urosepsis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Joint dislocation	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Meniscus injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Wrist fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Electrocardiogram QT prolonged	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Electroencephalogram abnormal	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Carotid arteriosclerosis	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Metabolic encephalopathy	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 events3 affected261 at risk EG0010 events0 affected49 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events2 affected261 at risk EG0010 events0 affected49 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Tracheomalacia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Haematoma	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Haemorrhage	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Peripheral venous disease	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Death	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected261 at risk EG0010 events0 affected49 at risk
Cardiac Tamponade/Perforation	Cardiac disorders	Non-systematic Assessment	EG0004 events3 affected261 at risk EG0010 events0 affected49 at risk
Stroke/Cerebrovascular Accident (CVA)	Nervous system disorders	Non-systematic Assessment	EG0001 events1 affected261 at risk EG0012 events2 affected49 at risk
Major Vascular Access Complication / Bleeding	Vascular disorders	Non-systematic Assessment	EG0003 events3 affected261 at risk EG0010 events0 affected49 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Supraventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG00012 events12 affected261 at risk EG0010 events0 affected49 at risk
Drug hypersensitivity	Immune system disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG00010 events10 affected261 at risk EG0012 events2 affected49 at risk
Atrial flutter	Cardiac disorders	Non-systematic Assessment	EG00014 events14 affected261 at risk EG0014 events4 affected49 at risk
Atrial tachycardia	Cardiac disorders	Non-systematic Assessment	EG0008 events8 affected261 at risk EG0010 events0 affected49 at risk
Atrioventricular block	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Atrioventricular block first degree	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Bradycardia	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0012 events2 affected49 at risk
Bundle branch block	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Cardiac failure acute	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Mitral valve stenosis	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG00014 events14 affected261 at risk EG0014 events4 affected49 at risk
Pericarditis	Cardiac disorders	Non-systematic Assessment	EG0008 events8 affected261 at risk EG0012 events2 affected49 at risk
Sinus bradycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0006 events4 affected261 at risk EG0010 events0 affected49 at risk
Supraventricular extrasystoles	Cardiac disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Tachyarrhythmia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Ventricular extrasystoles	Cardiac disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0012 events2 affected49 at risk
Intracardiac mass	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Pericardial effusion	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Dermoid cyst	Congenital, familial and genetic disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Cerumen impaction	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Vertigo positional	Ear and labyrinth disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hyperthyroidism	Endocrine disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Thyroid mass	Endocrine disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Cataract	Eye disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Eye pain	Eye disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Vision blurred	Eye disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0012 events2 affected49 at risk
Visual impairment	Eye disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0014 events4 affected49 at risk
Vitreous floaters	Eye disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG00012 events12 affected261 at risk EG0010 events0 affected49 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Haemorrhoids	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Inguinal hernia	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Large intestine polyp	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Melaena	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Periodontal disease	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Rectal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Abdominal discomfort	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Application site laceration	General disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Chest discomfort	General disorders	Non-systematic Assessment	EG0008 events8 affected261 at risk EG0014 events4 affected49 at risk
Chest pain	General disorders	Non-systematic Assessment	EG00034 events31 affected261 at risk EG0011 events1 affected49 at risk
Fatigue	General disorders	Non-systematic Assessment	EG00010 events10 affected261 at risk EG0012 events2 affected49 at risk
Local swelling	General disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Oedema	General disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Peripheral swelling	General disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0012 events2 affected49 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Oedema peripheral	General disorders	Non-systematic Assessment	EG00012 events12 affected261 at risk EG0010 events0 affected49 at risk
Hypersensitivity	Immune system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Acute sinusitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0012 events2 affected49 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Conjunctivitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Conjunctivitis viral	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Corona virus infection	Infections and infestations	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0012 events2 affected49 at risk
Gastroenteritis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Gastroenteritis viral	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Gingivitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Localised infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Medical device site infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pneumonia	Infections and infestations	Non-systematic Assessment	EG00012 events8 affected261 at risk EG0012 events2 affected49 at risk
Skin infection	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Tooth abscess	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG00010 events10 affected261 at risk EG0012 events2 affected49 at risk
Viral upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG00010 events10 affected261 at risk EG0010 events0 affected49 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Excoriation	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Foot fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Nail avulsion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Rib fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Scapula fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Vascular access site bruising	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Vascular access site swelling	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Wound secretion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Wrist fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Blood creatinine increased	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Blood sodium decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Heart rate increased	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0014 events4 affected49 at risk
Weight increased	Investigations	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0014 events4 affected49 at risk
Blood uric acid increased	Investigations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Blood cholesterol increased	Investigations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
C-reactive protein increased	Investigations	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Fluid overload	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Gout	Metabolism and nutrition disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hyponatraemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Exostosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Groin pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0012 events2 affected49 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Synovitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Carotid arteriosclerosis	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG00014 events14 affected261 at risk EG0010 events0 affected49 at risk
Headache	Nervous system disorders	Non-systematic Assessment	EG00014 events14 affected261 at risk EG0010 events0 affected49 at risk
Migraine with aura	Nervous system disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0012 events2 affected49 at risk
Presyncope	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0012 events2 affected49 at risk
Sciatica	Nervous system disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0014 events4 affected49 at risk
Vestibular migraine	Nervous system disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0012 events2 affected49 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Acute kidney injury	Renal and urinary disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Dysuria	Renal and urinary disorders	Non-systematic Assessment	EG0006 events4 affected261 at risk EG0010 events0 affected49 at risk
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Hydronephrosis	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected40 at risk
Renal pain	Renal and urinary disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Dysuria, Pollakiuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Pollakiuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0012 events2 affected49 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00028 events28 affected261 at risk EG0014 events4 affected49 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pulmonary haemorrhageq	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0012 events2 affected49 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk
Angioedema	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0006 events6 affected261 at risk EG0010 events0 affected49 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Psoriasis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Urticaria	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Arterial haemorrhage	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Arteriovenous fistula	Vascular disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Essential hypertension	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Haematoma	Vascular disorders	Non-systematic Assessment	EG00014 events14 affected261 at risk EG0012 events2 affected49 at risk
Haemorrhage	Vascular disorders	Non-systematic Assessment	EG0004 events4 affected261 at risk EG0010 events0 affected49 at risk
Hypertension	Vascular disorders	Non-systematic Assessment	EG00024 events22 affected261 at risk EG0012 events2 affected49 at risk
Hypotension	Vascular disorders	Non-systematic Assessment	EG00010 events8 affected261 at risk EG0012 events2 affected49 at risk
Labile blood pressure	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Peripheral venous disease	Vascular disorders	Non-systematic Assessment	EG0002 events2 affected261 at risk EG0010 events0 affected49 at risk
Accelerated hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected261 at risk EG0012 events2 affected49 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

ID	Title	Description
BG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).
BG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VISITAG SURPOINT Module STSF Catheter With EPU	Participants with symptomatic paroxysmal atrial fibrillation (PAF) who have failed at least one antiarrhythmic drug were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH Surround Flow (STSF) catheter with external processing unit (EPU).	2	261	53	261	139	261
EG001	VISITAG SURPOINT Module ST Catheter With EPU	Participants with symptomatic PAF who have failed at least one antiarrhythmic drug, were treated with electrophysiology mapping and radiofrequency (RF) ablation using VISITAG SURPOINT module with THERMOCOOL SMARTTOUCH (ST) catheter with EPU.	0	49	6	49	24	49