Trial Outcomes & Findings for Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System (NCT NCT05293639)

Last Updated: 2025-05-25

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/Cerebrovascular accident (CVA), Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

Recruitment status

COMPLETED

Study phase

Target enrollment

362 participants

Primary outcome timeframe

From Day 0 to Day 7 post catheter insertion on Day 0

Results posted on

2025-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Safety Analysis Set Participants enrolled in the pilot phase with symptomatic paroxysmal atrial fibrillation (PAF) and had an insertion of the Biosense Incorporated Webster (BWI) Irreversible Electroporation (IRE) Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic PAF.	Pivotal Roll-In Analysis Set Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the BWI IRE Ablation System and PFA delivery, underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Main Safety Analysis Set Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.
Overall Study STARTED	21	64	277
Overall Study COMPLETED	20	62	269
Overall Study NOT COMPLETED	1	2	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Pilot Safety Analysis Set Participants enrolled in the pilot phase with symptomatic paroxysmal atrial fibrillation (PAF) and had an insertion of the Biosense Incorporated Webster (BWI) Irreversible Electroporation (IRE) Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic PAF.	Pivotal Roll-In Analysis Set Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the BWI IRE Ablation System and PFA delivery, underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Main Safety Analysis Set Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.
Overall Study Withdrawal by Subject	1	1	2
Overall Study Death	0	1	0
Overall Study Lost to Follow-up	0	0	5
Overall Study Other	0	0	1

Baseline Characteristics

Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Safety Analysis Set n=21 Participants Participants enrolled in the pilot phase with symptomatic paroxysmal atrial fibrillation (PAF) and had an insertion of the Biosense Incorporated Webster (BWI) Irreversible Electroporation (IRE) Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=64 Participants Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the BWI IRE Ablation System and PFA delivery, underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Main Safety Analysis Set n=277 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Total n=362 Participants Total of all reporting groups
Age, Continuous Age (Year)	62.1 Years STANDARD_DEVIATION 10.20 • n=5 Participants	61.2 Years STANDARD_DEVIATION 8.97 • n=7 Participants	61.5 Years STANDARD_DEVIATION 10.30 • n=5 Participants	61.5 Years STANDARD_DEVIATION 10.05 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	26 Participants n=7 Participants	99 Participants n=5 Participants	134 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	38 Participants n=7 Participants	178 Participants n=5 Participants	228 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	57 Participants n=7 Participants	215 Participants n=5 Participants	292 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	6 Participants n=7 Participants	55 Participants n=5 Participants	62 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized White	20 Participants n=5 Participants	54 Participants n=7 Participants	228 Participants n=5 Participants	302 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	25 Participants n=5 Participants	28 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Day 0 to Day 7 post catheter insertion on Day 0

Population: mITT analysis set included all participants enrolled in the pivotal main phase who met eligibility criteria and had insertion of the study catheter. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=272 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pivotal Main Phase Modified Intent-To-Treat (mITT) Analysis Set: Number of Participants With Primary Adverse Events (PAEs)	8 Participants	—

PRIMARY outcome

Timeframe: From Day 0 to Day 7 post catheter insertion on Day 0

Population: Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here, "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. PAEs included the following AEs: Phrenic Nerve Paralysis (permanent), Stroke/CVA, Major Vascular Access Complication/Bleeding, Thromboembolism, Myocardial Infarction, Transient Ischemic Attack (TIA), Pericarditis, Pulmonary Edema (Respiratory Insufficiency), Heart Block, and Vagal Nerve Injury/ Gastroparesis.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=20 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=63 Participants Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Primary Adverse Events (PAEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 91 to Day 365 post catheter insertion on Day 0

Population: PP analysis set included all participants enrolled in the pivotal main phase who were treated for the study-related arrhythmia with the study catheter and without protocol deviations that would affect the scientific integrity of the study. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\], or atrial flutter \[AFL\] of unknown origin positive) episodes based on electrocardiographic data (greater than or equal to \[\>=\] 30 seconds on an electrocardiogram \[ECG\], sponsor-provided cardiac event monitor \[CEM\], or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion procedure) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any Direct Current Cardioversion (DCCV) procedure were reported.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=246 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pivotal Main Phase Per-Protocol (PP) Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia	183 Participants	—

PRIMARY outcome

Timeframe: Day 91 to Day 365 post catheter insertion on Day 0

Population: Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Number of Participants With freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin positive) episodes based on electrocardiographic data (\>=30 seconds on an ECG, CEM, or Holter device) during the effectiveness evaluation period (Day 91-365 post catheter insertion) and freedom from the following failure modes: acute procedural failure, repeat ablation failure, non-study catheter failure, AAD failure, continuous AF/AT/AFL of unknown origin on ECG, any DCCV procedure were reported.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=20 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=63 Participants Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Number of Participants With Freedom of Documented Atrial Tachyarrhythmia	16 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline, and 12 months post catheter insertion on Day 0

Population: PP analysis aet included all participants enrolled in the pivotal main phase who were treated for the study-related arrhythmia with the study catheter and without protocol deviations that would affect the scientific integrity of the study. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated Health Related Quality of Life (HRQoL) and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus (\[Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered\*6\])\*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=239 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pivotal Main Phase PP Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score	32.03 score on a scale Standard Deviation 23.075	—

SECONDARY outcome

Timeframe: Baseline, and 12 months post catheter insertion on Day 0

Population: Pilot phase used the safety analysis set, included participants enrolled in the Pilot phase and had insertion of the study catheter (with or without delivery of PFA). Pivotal roll-In phase analysis set included all participants enrolled and had insertion of the study catheter and undergone PFA delivery with the IRE ablation system. Here "N" (Overall number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.

Change from baseline in overall AFEQT total score were reported. Change in the AFEQT score included 20 questions on a 7-point Likert scale. Questions 1-18 evaluated HRQoL and questions 19-20 were related to the patient's satisfaction with treatment. The first 18 questions were used to calculate the overall AFEQT score. The total AFEQT scores was calculated as 100 minus (\[Sum of severity for all questions answered minus number of questions answered) divided by total number of questions answered\*6\])\*100. The overall AFEQT scores ranged from 0 (complete disability) to 100 (no disability). Therefore, a positive change in score corresponded to improvement in QoL.

Outcome measures

Outcome measures
Measure	Pivotal Main Phase mITT Analysis Set n=20 Participants Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=62 Participants Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the Biosense Webster (BWI) Irreversible Electroporation (IRE) Ablation System and PFA delivery, underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic paroxysmal AF.
Pilot Safety Analysis Set and Pivotal Roll-In Analysis Set: Change From Baseline in Overall Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT) Total Score	31.13 score on a scale Standard Deviation 27.150	34.98 score on a scale Standard Deviation 24.553

Adverse Events

Pilot Safety Analysis Set

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Pivotal Roll-In Analysis Set

Serious events: 7 serious events

Other events: 23 other events

Deaths: 1 deaths

Pivotal Main Safety Analysis Set

Serious events: 31 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Reecha Sharma

Johnson & Johnson MedTech

Phone: 949.789.3919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Pilot Safety Analysis Set n=21 participants at risk Participants enrolled in the pilot phase with symptomatic paroxysmal atrial fibrillation (PAF) and had an insertion of the Biosense Incorporated Webster (BWI) Irreversible Electroporation (IRE) Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=64 participants at risk Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the BWI IRE Ablation System and PFA delivery, underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Main Safety Analysis Set n=277 participants at risk Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Atrial fibrillation	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Atrial flutter	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Bradycardia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Cardiac arrest	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Cardiac failure acute	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Cardiac tamponade	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Pericardial effusion	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.1% 3/277 • Number of events 3 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Pericarditis	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Sinus arrest	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Endocrine disorders Thyroid mass	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Non-cardiac chest pain	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Pyrexia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Sudden cardiac death	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Immune system disorders Anaphylactic reaction	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Infections and infestations Diverticulitis	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Infections and infestations Pneumonia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Infections and infestations Urinary tract infection	4.8% 1/21 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Injury, poisoning and procedural complications Vascular access site haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Metabolism and nutrition disorders Dehydration	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Nervous system disorders Cerebrovascular accident	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Nervous system disorders Migraine	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Nervous system disorders Presyncope	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Nervous system disorders Syncope	4.8% 1/21 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Renal and urinary disorders Urinary retention	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Vascular disorders Aortic aneurysm	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.

Other adverse events
Measure	Pilot Safety Analysis Set n=21 participants at risk Participants enrolled in the pilot phase with symptomatic paroxysmal atrial fibrillation (PAF) and had an insertion of the Biosense Incorporated Webster (BWI) Irreversible Electroporation (IRE) Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and pulsed field ablation (PFA) for treatment of Antiarrhythmic Drug (AAD) refractory symptomatic PAF.	Pivotal Roll-In Analysis Set n=64 participants at risk Participants enrolled in the pivotal roll-In phase with symptomatic paroxysmal atrial fibrillation (PAF) had an insertion of the BWI IRE Ablation System and PFA delivery, underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.	Pivotal Main Safety Analysis Set n=277 participants at risk Participants enrolled in the in pivotal main phase with symptomatic PAF had an insertion of the BWI IRE Ablation System (with or without delivery of PFA), underwent electrophysiology mapping and PFA for treatment of AAD refractory symptomatic PAF.
Eye disorders Vitreous detachment	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Eye disorders Vitreous floaters	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Abdominal distension	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Abdominal pain	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Constipation	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Diarrhoea	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Dysphagia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Blood and lymphatic system disorders Anaemia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Atrial flutter	4.8% 1/21 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	2.9% 8/277 • Number of events 9 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Atrial tachycardia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	3.1% 2/64 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Pericarditis	4.8% 1/21 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Sinus arrest	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Cardiac disorders Sinus tachycardia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Congenital, familial and genetic disorders Dermoid cyst	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Ear and labyrinth disorders Tinnitus	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Endocrine disorders Hypothyroidism	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Eye disorders Cataract	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Eye disorders Conjunctival haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Eye disorders Vision blurred	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Eye disorders Visual impairment	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.8% 5/277 • Number of events 5 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Inguinal hernia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Odynophagia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Umbilical hernia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Vomiting	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Gastrointestinal disorders Ileus	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Chest discomfort	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.1% 3/277 • Number of events 3 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Chest pain	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 2 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Fatigue	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	4.7% 3/64 • Number of events 3 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Hernia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Oedema peripheral	4.8% 1/21 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
General disorders Pyrexia	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.72% 2/277 • Number of events 3 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/277 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Immune system disorders Hypersensitivity	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	1.6% 1/64 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Infections and infestations Acute sinusitis	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.
Infections and infestations Appendicitis	0.00% 0/21 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.00% 0/64 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.	0.36% 1/277 • Number of events 1 • From screening up to 12 months Adverse Events from enrollment through study exit were reported. SAE and NSAE presented below include PAE and all-cause mortality events.