Trial Outcomes & Findings for Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion) (NCT NCT02100228)

NCT ID: NCT02100228

Last Updated: 2018-05-23

Results Overview

An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1500 participants
• Primary outcome timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
• Results posted on: 2018-05-23

Participant Flow

Participant milestones

Measure	Apixaban Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Study STARTED	753	747
Overall Study COMPLETED	678	657
Overall Study NOT COMPLETED	75	90

Reasons for withdrawal

Measure	Apixaban Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Overall Study Other	19	19
Overall Study Administrative reason	0	1
Overall Study Inclusion/Exclusion criteria not met	12	16
Overall Study Non-compliance	0	3
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	27	37
Overall Study Adverse Event	16	12
Overall Study Death	1	1

Baseline Characteristics

Study Of The Blood Thinner, Apixaban, For Patients Who Have An Abnormal Heart Rhythm (Atrial Fibrillation) And Expected To Have Treatment To Put Them Back Into A Normal Heart Rhythm (Cardioversion)

Baseline characteristics by cohort

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.	Total n=1500 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 12.19 • n=5 Participants	64.5 years STANDARD_DEVIATION 12.76 • n=7 Participants	64.6 years STANDARD_DEVIATION 12.47 • n=5 Participants
Sex: Female, Male Female	248 Participants n=5 Participants	250 Participants n=7 Participants	498 Participants n=5 Participants
Sex: Female, Male Male	505 Participants n=5 Participants	497 Participants n=7 Participants	1002 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	99 Participants n=7 Participants	199 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	645 Participants n=5 Participants	639 Participants n=7 Participants	1284 Participants n=5 Participants
Race/Ethnicity, Customized White	654 Participants n=5 Participants	648 Participants n=7 Participants	1302 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Asian	78 Participants n=5 Participants	76 Participants n=7 Participants	154 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Population: Full analysis set included all randomized participants.

An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).

Outcome measures

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Acute Stroke Event	0 participants	6 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Population: Full analysis set included all randomized participants.

Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.

Outcome measures

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Systemic Embolism Event	0 participants Interval 0.0 to 0.0	0 participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Population: Safety data set included all treated participants (randomized participants who received at least one dose of study drug).

Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.

Outcome measures

Measure	Apixaban n=735 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=721 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Major Bleeding Event	3 participants	6 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Population: Safety data set included all treated participants (randomized participants who received at least one dose of study drug).

Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.

Outcome measures

Measure	Apixaban n=735 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=721 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Clinically Relevant Non-Major Bleeding Events	11 participants	13 participants

PRIMARY outcome

Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)

Population: Full analysis set included all randomized participants.

Outcome measures

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With All Cause Death	2 participants	1 participants

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Full analysis set included all randomized participants. Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.

Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.

Outcome measures

Measure	Apixaban n=510 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=511 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Time to First Attempt of Cardioversion	2.0 days Interval 1.0 to 93.0	2.0 days Interval 1.0 to 126.0

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Full analysis set included all randomized participants. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.

Outcome measures

Measure	Apixaban n=496 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=494 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Different Type of Cardioversion Events Electrical	461 participants	464 participants
Number of Participants With Different Type of Cardioversion Events Pharmacologic	35 participants	30 participants

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Full analysis set included all randomized participants.

Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.

Outcome measures

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Cardioversion Attempt of Participants No Cardioversion Attempt	234 participants	224 participants
Number of Cardioversion Attempt of Participants 1 Cardioversion Attempt	488 participants	496 participants
Number of Cardioversion Attempt of Participants More than 2 Cardioversion Attempts	31 participants	27 participants

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Safety data set included all treated participants (randomized participants who received at least one dose of study drug). Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).

Outcome measures

Measure	Apixaban n=719 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=712 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants With Their Rhythm Status Normal Sinus	1 participants	2 participants
Number of Participants With Their Rhythm Status Atrial Fibrillation	715 participants	704 participants
Number of Participants With Their Rhythm Status Atrial Flutter	3 participants	6 participants

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Full analysis set included all randomized participants. Here "N" signifies number of participants who were evaluable for this specified outcome measure.

Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.

Outcome measures

Measure	Apixaban n=330 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=346 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Duration of Hospital Stay of Participants	45.36 hours Interval 0.4 to 747.0	49.47 hours Interval 0.6 to 709.6

SECONDARY outcome

Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Population: Full analysis set included all randomized participants.

An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.

Outcome measures

Measure	Apixaban n=753 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=747 Participants Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Number of Participants Who Used Image Guidance Approach	383 participants	399 participants

Adverse Events

Apixaban

Serious events: 100 serious events

Other events: 70 other events

Deaths: 1 deaths

Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)

Serious events: 112 serious events

Other events: 101 other events

Deaths: 3 deaths

Serious adverse events

Measure	Apixaban n=735 participants at risk Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=721 participants at risk Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Blood and lymphatic system disorders HAEMORRHAGIC ANAEMIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ANGINA PECTORIS	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIAL FIBRILLATION	3.7% 27/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	5.5% 40/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIAL FLUTTER	0.41% 3/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.83% 6/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIAL THROMBOSIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.42% 3/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIOVENTRICULAR DISSOCIATION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders BRADYCARDIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CARDIAC FAILURE	0.68% 5/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.97% 7/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CARDIAC FAILURE ACUTE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	1.2% 9/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.97% 7/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CARDIOGENIC SHOCK	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CONGESTIVE CARDIOMYOPATHY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CORONARY ARTERY DISEASE	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.83% 6/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders CORONARY ARTERY STENOSIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ISCHAEMIC CARDIOMYOPATHY	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders MITRAL VALVE INCOMPETENCE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders MITRAL VALVE PROLAPSE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.42% 3/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders PALPITATIONS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders PERICARDITIS CONSTRICTIVE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders SINUS ARREST	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders SINUS NODE DYSFUNCTION	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders TACHYARRHYTHMIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders TACHYCARDIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders TACHYCARDIA INDUCED CARDIOMYOPATHY	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders TRICUSPID VALVE INCOMPETENCE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Congenital, familial and genetic disorders ADENOMATOUS POLYPOSIS COLI	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Congenital, familial and genetic disorders HYPERTROPHIC CARDIOMYOPATHY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Endocrine disorders ADRENAL HAEMORRHAGE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Endocrine disorders TOXIC NODULAR GOITRE	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders ENTEROCOLITIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders FEMORAL HERNIA INCARCERATED	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders GASTRIC ULCER	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders GASTRITIS	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders MELAENA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders MESENTERIC PANNICULITIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders OEDEMATOUS PANCREATITIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders PEPTIC ULCER	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders PEPTIC ULCER HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders ASTHENIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders CHEST PAIN	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders HERNIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders MUCOSAL HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders NON-CARDIAC CHEST PAIN	0.41% 3/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
General disorders SUDDEN DEATH	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Hepatobiliary disorders DRUG-INDUCED LIVER INJURY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Hepatobiliary disorders HEPATIC CONGESTION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Immune system disorders DRUG HYPERSENSITIVITY	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations ABSCESS LIMB	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations BRONCHITIS	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations CELLULITIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations INFECTION	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations INFLUENZA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations INTESTINAL SEPSIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations LUNG INFECTION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations PNEUMONIA	0.41% 3/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.69% 5/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations SEPSIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations SEPTIC SHOCK	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations URINARY TRACT INFECTION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Infections and infestations UROSEPSIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications ARTERIAL BYPASS THROMBOSIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications EYE INJURY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications FALL	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications HEAD INJURY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.42% 3/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications TRAUMATIC INTRACRANIAL HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations COMPUTERISED TOMOGRAM CORONARY ARTERY ABNORMAL	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations FUNCTIONAL RESIDUAL CAPACITY DECREASED	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations HEPATIC ENZYME INCREASED	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations INTERNATIONAL NORMALISED RATIO ABNORMAL	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations WEIGHT DECREASED	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Metabolism and nutrition disorders DEHYDRATION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE LEUKAEMIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO BONE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders BRAIN INJURY	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders CEREBRAL INFARCTION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.42% 3/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders DEMENTIA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders DIZZINESS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders PRESYNCOPE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders SEIZURE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders SYNCOPE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.28% 2/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.28% 2/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Psychiatric disorders DEPRESSION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.69% 5/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Renal and urinary disorders HAEMATURIA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Renal and urinary disorders POSTRENAL FAILURE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Renal and urinary disorders RENAL HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.41% 3/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders MEDIASTINAL CYST	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders MEDIASTINAL HAEMATOMA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.27% 2/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.41% 3/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.28% 2/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders PULMONARY SARCOIDOSIS	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Skin and subcutaneous tissue disorders DIABETIC FOOT	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Skin and subcutaneous tissue disorders PETECHIAE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Skin and subcutaneous tissue disorders SUBCUTANEOUS EMPHYSEMA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders ARTERIAL HAEMORRHAGE	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders ARTERIOVENOUS FISTULA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders HAEMATOMA	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.14% 1/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders HYPERTENSION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders HYPERTENSIVE CRISIS	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.28% 2/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Vascular disorders HYPOTENSION	0.14% 1/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	0.00% 0/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.

Other adverse events

Measure	Apixaban n=735 participants at risk Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) n=721 participants at risk Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
Cardiac disorders ATRIAL FIBRILLATION	5.9% 43/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	6.4% 46/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Cardiac disorders ATRIAL THROMBOSIS	2.3% 17/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	1.8% 13/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations INTERNATIONAL NORMALISED RATIO ABNORMAL	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	2.6% 19/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	3.7% 27/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	2.0% 15/735 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.	1.1% 8/721 • From baseline up to 30 days after cardioversion or 90 days after randomization, if cardioversion was not performed Same event may appear as adverse event (AE) and serious adverse event (SAE), what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety data set included all treated participants.

Additional Information

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Results disclosure agreements

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Restriction type: OTHER