Trial Outcomes & Findings for Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (NCT NCT02866175)

NCT ID: NCT02866175

Last Updated: 2020-05-06

Results Overview

Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1506 participants
• Primary outcome timeframe: Day 1 to 12 months postdose
• Results posted on: 2020-05-06

Participant Flow

A total of 1506 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study; 1486 participants received treatment. A total of 20 participants (5 Edoxaban and 15 Vitamin K Antagonist) did not receive treatment.

Participant milestones

Measure	Edoxaban Regimen Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
Overall Study STARTED	751	755
Overall Study COMPLETED	616	580
Overall Study NOT COMPLETED	135	175

Reasons for withdrawal

Measure	Edoxaban Regimen Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.
Overall Study Adverse Event	56	54
Overall Study Withdrawal by Subject	31	52
Overall Study Death	30	23
Overall Study Other	7	14
Overall Study Progressive disease	1	1
Overall Study Lost to Follow-up	2	0
Overall Study Lack of Efficacy	0	1
Overall Study Physician Decision	3	15
Overall Study Did not receive treatment	5	15

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration.	Total n=1506 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=751 Participants	0 Participants n=755 Participants	0 Participants n=1506 Participants
Age, Categorical Between 18 and 65 years	226 Participants n=751 Participants	202 Participants n=755 Participants	428 Participants n=1506 Participants
Age, Categorical >=65 years	525 Participants n=751 Participants	553 Participants n=755 Participants	1078 Participants n=1506 Participants
Age, Continuous	69.4 years STANDARD_DEVIATION 9.74 • n=751 Participants	70.1 years STANDARD_DEVIATION 9.51 • n=755 Participants	69.7 years STANDARD_DEVIATION 9.63 • n=1506 Participants
Sex: Female, Male Female	194 Participants n=751 Participants	192 Participants n=755 Participants	386 Participants n=1506 Participants
Sex: Female, Male Male	557 Participants n=751 Participants	563 Participants n=755 Participants	1120 Participants n=1506 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Romania	17 participants n=751 Participants	22 participants n=755 Participants	39 participants n=1506 Participants
Region of Enrollment Hungary	49 participants n=751 Participants	54 participants n=755 Participants	103 participants n=1506 Participants
Region of Enrollment Ukraine	169 participants n=751 Participants	175 participants n=755 Participants	344 participants n=1506 Participants
Region of Enrollment United Kingdom	6 participants n=751 Participants	9 participants n=755 Participants	15 participants n=1506 Participants
Region of Enrollment Portugal	12 participants n=751 Participants	12 participants n=755 Participants	24 participants n=1506 Participants
Region of Enrollment Switzerland	2 participants n=751 Participants	5 participants n=755 Participants	7 participants n=1506 Participants
Region of Enrollment Spain	58 participants n=751 Participants	57 participants n=755 Participants	115 participants n=1506 Participants
Region of Enrollment Austria	18 participants n=751 Participants	8 participants n=755 Participants	26 participants n=1506 Participants
Region of Enrollment Netherlands	3 participants n=751 Participants	7 participants n=755 Participants	10 participants n=1506 Participants
Region of Enrollment South Korea	50 participants n=751 Participants	41 participants n=755 Participants	91 participants n=1506 Participants
Region of Enrollment Belgium	43 participants n=751 Participants	37 participants n=755 Participants	80 participants n=1506 Participants
Region of Enrollment Taiwan	32 participants n=751 Participants	46 participants n=755 Participants	78 participants n=1506 Participants
Region of Enrollment Poland	74 participants n=751 Participants	66 participants n=755 Participants	140 participants n=1506 Participants
Region of Enrollment Italy	69 participants n=751 Participants	84 participants n=755 Participants	153 participants n=1506 Participants
Region of Enrollment France	21 participants n=751 Participants	20 participants n=755 Participants	41 participants n=1506 Participants
Region of Enrollment Lithuania	24 participants n=751 Participants	21 participants n=755 Participants	45 participants n=1506 Participants
Region of Enrollment Serbia	17 participants n=751 Participants	11 participants n=755 Participants	28 participants n=1506 Participants
Region of Enrollment Germany	87 participants n=751 Participants	80 participants n=755 Participants	167 participants n=1506 Participants

PRIMARY outcome

Timeframe: Day 1 to 12 months postdose

Population: First major or clinically relevant non-major bleeding was assessed in the Intent-to-Treat Analysis Set.

Participants' first major or clinically relevant non-major bleeding (MCRB) events were reported. International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: MCRB, major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.

Outcome measures

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Composite MCRB	128 Participants	152 Participants
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Major bleeding	39 Participants	44 Participants
Number of Participants With Adjudicated Major or Clinically Relevant Non-major Bleeding As First Event Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Clinically relevant non-major bleeding	89 Participants	108 Participants

SECONDARY outcome

Timeframe: Day 1 to 12 months postdose

Population: All major, clinically relevant non-major, and minor bleeding events were assessed in the Intent-to-Treat Analysis Set.

All major, clinically relevant non-major and minor bleeding are reported for the secondary outcome. Participants may have experiences more than 1 bleeding event, all occurrences are reported. Participants with International Society on Thrombosis and Hemostasis (ISTH) defined bleeding events included: major or clinically relevant non-major bleeding (MCRB), major bleeding, including fatal bleeding (intracranial and non-intracranial), symptomatic intracranial hemorrhage, symptomatic bleeding in a critical area or organ, and clinically overt and causing ≥2.0 g/dL adjusted hemoglobin loss, clinically relevant non-major (CRNM) bleeding, minor bleedings, any bleeding (defined as the composite of major, CRNM, and minor bleeding), life-threatening bleeding, provoked (spontaneous, instrumental/traumatic, unknown) bleeding, and spontaneous bleeding.

Outcome measures

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Major bleeding	45 Participants	48 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Clinically relevant non-major bleeding	97 Participants	114 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Minor bleeding	116 Participants	125 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Symptomatic intracranial hemorrhage	4 Participants	9 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Fatal major bleeding	1 Participants	7 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Fatal intracranial hemorrhage	0 Participants	4 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Life-threatening bleeding	5 Participants	8 Participants
Number of Participants With Adjudicated Major, Clinically Relevant Non-major and Minor Bleeding (All Events) Defined by International Society on Thrombosis and Haemostasis Following Edoxaban-based Regimen Compared With Vitamin K Antagonist-Based Regimen Spontaneous bleeding	184 Participants	210 Participants

SECONDARY outcome

Timeframe: Day 1 to 12 months postdose

Population: Major, minor, and minimal bleeding was assessed in the Intent-to-Treat Analysis Set.

Thrombolysis in Myocardial Infarction (TIMI) defined bleeding events included: Major bleeding (including fatal bleeding and non-fatal bleeding [fulfilling the TIMI major bleeding definition], major or minor bleeding, minor bleeding, minimal bleeding, and any bleeding (defined as composite of major, minor, and minimal bleeding)

Outcome measures

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Major bleeding	15 Participants	24 Participants
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Fatal bleeding	1 Participants	4 Participants
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Major or minor bleeding	124 Participants	144 Participants
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Minor bleeding	113 Participants	126 Participants
Number of Participants With Adjudicated Major, Minor, and Minimal Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Definition Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Minimal bleeding	117 Participants	131 Participants

SECONDARY outcome

Timeframe: Day 1 to 12 months postdose

Population: BARC type 1, 2, 3, and 5 bleeding was assessed in the Intent-to-Treat Analysis Set.

Bleeding Academic Research Consortium (BARC) bleeding events included: Bleeding (defined by BARC type 3 or 5), bleeding (defined by BARC type 2, 3, or 5), and any bleeding (defined as the composite of BARC type 1, 2, 3, or 5), where increases in BARC type indicate worse outcome.

Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consultation; Type 2: any overt, actionable sign of hemorrhage that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation; Type 3: Overt bleeding plus hemoglobin drop of 3 to ≤5 g/dL (3a), ≥5 g/dl (3b), and intracranial hemorrhage (3c) Type 5: Fatal bleeding

Outcome measures

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Bleeding (BARC Type 3 or 5)	36 Participants	42 Participants
Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Bleeding (BARC Type 2, 3, or 5)	124 Participants	144 Participants
Number of Participants With Bleeding Academic Research Consortium (BARC) Type 1, 2, 3, and 5 Bleeding According to the BARC Definitions Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Bleeding (BARC Type 1, 2, 3, or 5)	207 Participants	242 Participants

SECONDARY outcome

Timeframe: Day 1 to 12 months postdose

Population: Efficacy endpoints were assessed in the Intent-to-Treat Analysis Set.

The main efficacy endpoints were defined as the composite of cardiovascular death (ARC), stroke (protocol defined), systemic embolic event (SEE), myocardial infarction (MI), or definite stent thrombosis.

Outcome measures

Measure	Edoxaban Regimen n=751 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=755 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Composite MEE event	49 Participants	46 Participants
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Cardiovascular death (ARC)	10 Participants	12 Participants
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Stroke (Protocol definition)	10 Participants	11 Participants
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Systemic Embolic Event	0 Participants	0 Participants
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Myocardial infarction	22 Participants	18 Participants
Number of Participants With Main Efficacy Endpoints For the Overall Study Period Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Definite stent thrombosis	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 1 to 30 days after the last dose

Population: Safety events were assessed in the Safety Analysis Set.

Treatment-emergent adverse events (TEAEs) in >1.0% of participants were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug.

Outcome measures

Measure	Edoxaban Regimen n=746 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=740 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Any TEAE	457 Participants	447 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Infections and Infestations	145 Participants	140 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Nasopharyngitis	25 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Pneumonia	20 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Bronchitis	19 Participants	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Urinary tract infection	14 Participants	19 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Respiratory tract infection	12 Participants	15 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Influenza	10 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Cardiac Disorders	136 Participants	134 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Cardiac failure	40 Participants	47 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Atrial fibrillation	39 Participants	41 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Bradycardia	10 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Cardiac failure congestive	8 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Ventricular extrasystoles	7 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Tachycardia	11 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen General Disorders & Administration Site Condition	113 Participants	98 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Non-cardiac chest pain	30 Participants	24 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Oedema peripheral	31 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Asthenia	21 Participants	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Chest pain	7 Participants	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Fatigue	11 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Gastrointestinal Disorders	110 Participants	83 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Diarrhoea	23 Participants	19 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Constipation	11 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Abdominal pain upper	6 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Gastritis	9 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Nausea	8 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dyspepsia	8 Participants	3 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Respiratory,Thoracic, and Mediastinal Disorders	87 Participants	72 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dyspnoea	22 Participants	26 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Cough	21 Participants	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dyspnoea exertional	18 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Chronic obstructive pulmonary disease	6 Participants	10 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Musculoskeletal and Connective Tissue Disorders	69 Participants	83 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Back pain	14 Participants	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Arthralgia	11 Participants	12 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Pain in extremity	5 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Myalgia	8 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Osteoarthritis	9 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Investigations	70 Participants	79 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Blood creatinine increased	15 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Alanine aminotransferase increased	8 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Blood pressure increased	12 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Creatinine renal clearance decreased	12 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Aspartate aminotransferase increased	7 Participants	11 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen International normalised ratio increased	0 Participants	12 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Nervous System Disorders	83 Participants	65 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dizziness	30 Participants	22 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Headache	19 Participants	12 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Syncope	8 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Vascular Disorders	55 Participants	62 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Hypertension	23 Participants	23 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Hypotension	14 Participants	14 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Hypertensive crisis	11 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Renal and Urinary Disorders	49 Participants	55 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Renal failure	11 Participants	12 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Acute kidney injury	8 Participants	13 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Renal impairment	7 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Injury, Poisoning, and Procedural Complications	44 Participants	44 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Fall	8 Participants	12 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Skin and Subcutaneous Tissue Disorders	55 Participants	33 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Pruritus	12 Participants	7 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Rash	10 Participants	9 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Metabolism and Nutrition Disorders	42 Participants	42 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Gout	11 Participants	4 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Blood and Lymphatic System Disorders	41 Participants	35 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Anaemia	19 Participants	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Psychiatric Disorder	23 Participants	20 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Insomnia	8 Participants	8 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Ear and Labyrinth Disorders	12 Participants	16 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Vertigo	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 1 to 30 days after the last dose

Population: Safety events were assessed in the Safety Analysis Set.

Study drug-related treatment-emergent adverse events (TEAEs) (experienced by 2 or more participants) were defined as events which started on or after first dose of the assigned study drug (edoxaban and VKA) or started prior to but then worsened after the first dose of the assigned study drug and were found to be related to treatment by the Investigator.

Outcome measures

Measure	Edoxaban Regimen n=746 Participants Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=740 Participants Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Nausea	2 Participants	0 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Skin and Subcutaneous Tissue Disorders	6 Participants	5 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Pruritus	2 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Any Related TEAE	57 Participants	48 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Blood and Lymphatic System Disorders	12 Participants	11 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Anaemia	9 Participants	7 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Haemorrhagic anaemia	0 Participants	2 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Normochromic normocytic anaemia	2 Participants	0 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Investigations	7 Participants	16 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen International normalised ratio increased	0 Participants	12 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Blood creatinine increased	3 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Creatinine renal clearance decreased	2 Participants	2 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Haemoglobin decreased	2 Participants	0 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Gastrointestinal Disorders	12 Participants	4 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Abdominal pain upper	3 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dyspepsia	3 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Rash	1 Participants	2 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Injury, Poisoning, and Procedural Complications	1 Participants	7 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Overdose	0 Participants	4 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Contusion	1 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen General Disorders & Administration Site Conditions	6 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Death	3 Participants	0 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Renal and Urinary Disorders	2 Participants	2 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Chronic kidney disease	1 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Renal failure	1 Participants	1 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Nervous System Disorders	3 Participants	0 Participants
Number of Participants With Study Drug-related Treatment-emergent Adverse Events (TEAEs) Experienced by 2 or More Participants Following Edoxaban-based Regimen Compared With Vitamin K Antagonist (VKA)-Based Regimen Dizziness	2 Participants	0 Participants

Adverse Events

Edoxaban Regimen

Serious events: 176 serious events

Other events: 457 other events

Deaths: 46 deaths

Vitamin K Antagonist Regimen

Serious events: 175 serious events

Other events: 447 other events

Deaths: 37 deaths

Serious adverse events

Measure	Edoxaban Regimen n=746 participants at risk Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=740 participants at risk Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Infections and infestations Appendicitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Sepsis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Bronchitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Erysipelas	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Respiratory tract infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Aeromonas infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure	3.9% 29/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	4.7% 35/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrial fibrillation	2.7% 20/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.9% 14/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Pneumonia	1.9% 14/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.8% 13/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Urinary tract infection	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Cellulitis	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Septic shock	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Cholecystitis infective	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Device-related infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Gangrene	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Gastroenteritis viral	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Implant site infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Infectious colitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Influenza	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Lower respiratory tract infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Meningitis cryptococcal	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Osteomyelitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Peritoneal abscess	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Postoperative wound infection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Sialoadenitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Sinusitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Streptococcal sepsis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Tracheobronchitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Urosepsis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Wound infection	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrosarcoma	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Anaemia	0.54% 4/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Hypochromic anaemia	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Iron deficiency anaemia	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Nephrogenic anaemia	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Pancytopenia	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Immune system disorders Amyloidosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Endocrine disorders Adrenal insufficiency	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Metabolism and nutrition disorders Diabetes mellitus	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Metabolism and nutrition disorders Decreased appetite	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Psychiatric disorders Confusional state	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Psychiatric disorders Suicide attempt	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Syncope	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Sciatica	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Brain oedema	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Carotid artery stenosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Cervicogenic headache	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Cognitive disorder	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Diabetic neuropathy	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Dizziness	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Monoparesis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Neuropathy peripheral	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Seizure	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Eye disorders Cataract	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Eye disorders Iridocyclitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure congestive	0.80% 6/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure acute	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.54% 4/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Sinus node dysfunction	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrial flutter	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure chronic	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Mitral valve incompetence	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Aortic valve stenosis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Bradycardia	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Tachycardia	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Ventricular fibrillation	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Ventricular tachycardia	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrial tachycardia	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrioventricular block second degree	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac arrest	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardio-respiratory arrest	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiogenic shock	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Coronary artery disease	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Coronary artery stenosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Acute left ventricular failure	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Adams-Stokes syndrome	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Angina unstable	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrioventricular block complete	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac ventricular thrombosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiovascular insufficiency	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Left ventricular dysfunction	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Pulseless electrical activity	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Sinus arrest	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Tachyarrhythmia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Ventricular arrhythmia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypertensive crisis	0.54% 4/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypertension	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Peripheral arterial occlusive disease	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Orthostatic hypotension	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Aortic dissection	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Extremity necrosis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypotension	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Peripheral artery occlusion	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.67% 5/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.2% 9/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Abdominal pain upper	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Diarrhoea	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Abdominal pain	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Gastric ulcer	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Inguinal hernia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Abdominal distension	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Acute abdomen	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Anal fissure	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Anal stenosis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Colitis ulcerative	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Crohn's disease	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Dental cyst	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Enterocolitis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Gastritis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Haemorrhoids	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Large intestine perforation	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Rectal polyp	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Cholecystitis acute	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.54% 4/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Cholelithiasis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Biliary fistula	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Cholecystitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Hepatitis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Hepatobiliary disorders Hepatorenal syndrome	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Diabetic foot	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Psoriasis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Urticaria	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Back pain	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Intervertebral disc protusion	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Arthralgia	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Monarthritis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Rheumatic disorder	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Acute kidney injury	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Renal failure	0.67% 5/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Nephrolithiasis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Calculus urethral	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders End stage renal disease	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Prerenal failure	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Renal artery stenosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Renal impairment	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Urethral stenosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Urinary retention	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.40% 3/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Reproductive system and breast disorders Prostatitis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Reproductive system and breast disorders Ovarian cyst	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Reproductive system and breast disorders Spermatocele	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Congenital, familial and genetic disorders Phimosis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Non-cardiac chest pain	0.80% 6/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Death	0.54% 4/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Sudden death	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Chest pain	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Vascular stent thrombosis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Asthenia	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Vascular stent restenosis	0.27% 2/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Chest discomfort	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Drowning	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Hernia	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Sudden cardiac death	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations International normalised ratio increased	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Fall	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Head injury	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Hip fracture	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Overdose	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.27% 2/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Arterial restenosis	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Compression fracture	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Concussion	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Costal cartilage fracture	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Hand fracture	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Humerus fracture	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Limb injury	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Product use issue	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Rib fracture	0.13% 1/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.00% 0/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Wound necrosis	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Surgical and medical procedures Coronary revascularisation	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Product Issues Device capturing issue	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.14% 1/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).

Other adverse events

Measure	Edoxaban Regimen n=746 participants at risk Participants who were randomized to Edoxaban 60 mg once-daily or 30 mg once-daily and clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used).	Vitamin K Antagonist Regimen n=740 participants at risk Participants who were randomized to VKA in combination with clopidogrel 75 mg once-daily (or in the presence of a documented clinical need prasugrel \[5 mg or 10 mg once-daily\] or ticagrelor \[90 mg twice-daily\] may be used) and aspirin (100 mg once-daily, for a minimum of 1 month and up to 12 months duration).
Infections and infestations Nasopharyngitis	3.4% 25/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.0% 22/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Pneumonia	2.7% 20/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.0% 22/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Bronchitis	2.5% 19/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	2.7% 20/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Urinary tract infection	1.9% 14/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	2.6% 19/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Respiratory tract infection	1.6% 12/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	2.0% 15/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Infections and infestations Influenza	1.3% 10/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure	5.4% 40/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	6.4% 47/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Atrial fibrillation	5.2% 39/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	5.5% 41/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Bradycardia	1.3% 10/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Cardiac failure congestive	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Ventricular extrasystoles	0.94% 7/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Cardiac disorders Tachycardia	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Non-cardiac chest pain	4.0% 30/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.2% 24/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Oedema peripheral	4.2% 31/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.0% 22/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Asthenia	2.8% 21/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.9% 14/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Chest pain	0.94% 7/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.5% 11/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
General disorders Fatigue	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.81% 6/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Diarrhoea	3.1% 23/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	2.6% 19/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Constipation	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Abdominal pain upper	0.80% 6/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.4% 10/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Gastritis	1.2% 9/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Nausea	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Gastrointestinal disorders Dyspepsia	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.41% 3/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.9% 22/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.5% 26/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Cough	2.8% 21/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.5% 11/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	2.4% 18/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.80% 6/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.4% 10/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Back pain	1.9% 14/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.9% 14/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Arthralgia	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.6% 12/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Pain in extremity	0.67% 5/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.8% 13/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Myalgia	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.2% 9/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations Blood creatinine increased	2.0% 15/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.8% 13/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations Alanine aminotransferase increased	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.8% 13/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations Blood pressure increased	1.6% 12/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations Creatinine renal clearance increased	1.6% 12/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations Aspartate aminotransferase increased	0.94% 7/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.5% 11/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Investigations International normalised ratio increased	0.00% 0/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.6% 12/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Dizziness	4.0% 30/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.0% 22/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Headache	2.5% 19/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.6% 12/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Nervous system disorders Syncope	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.81% 6/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypertension	3.1% 23/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	3.1% 23/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypotension	1.9% 14/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.9% 14/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Vascular disorders Hypertensive crisis	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Renal failure	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.6% 12/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Acute kidney injury	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.8% 13/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Renal and urinary disorders Renal impairment	0.94% 7/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Injury, poisoning and procedural complications Fall	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.6% 12/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Pruritus	1.6% 12/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.95% 7/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Skin and subcutaneous tissue disorders Rash	1.3% 10/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.2% 9/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Metabolism and nutrition disorders Gout	1.5% 11/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.54% 4/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Blood and lymphatic system disorders Anaemia	2.5% 19/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	2.7% 20/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Psychiatric disorders Insomnia	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	1.1% 8/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).
Ear and labyrinth disorders Vertigo	1.1% 8/746 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).	0.68% 5/740 • Adverse events were collected from Day 1 to 30 days after last dose, up to 2 years, 4 months. Adverse events were reported from the Safety Analysis Set (746 Edoxaban regimen; 740 Vitamin K Antagonist regimen).

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo, Inc.

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

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