Trial Outcomes & Findings for A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) (NCT NCT03647475)

Last Updated: 2021-11-01

Results Overview

Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

Recruitment status

COMPLETED

Study phase

Target enrollment

752 participants

Primary outcome timeframe

One Month to one year

Results posted on

2021-11-01

Participant Flow

Per protocol, the 752 subjects enrolled in the US \& Japan were pooled with A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients" (NCT03344653). Subjects enrolled under NCT03344653 were in regions outside of the US and Japan.

Participant milestones

Participant milestones
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Overall Study STARTED	752
Overall Study NCT03647475 - Included in One Month Clear Analysis Population	601
Overall Study NCT03344653- Included in One Month Clear Analysis Population	905
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	677

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Age, Categorical <=18 years	0 Participants n=1506 Participants
Age, Categorical Between 18 and 65 years	241 Participants n=1506 Participants
Age, Categorical >=65 years	1265 Participants n=1506 Participants
Age, Continuous	74 years STANDARD_DEVIATION 9.5 • n=1506 Participants
Sex: Female, Male Female	487 Participants n=1506 Participants
Sex: Female, Male Male	1019 Participants n=1506 Participants
Region of Enrollment United States	564 Participants n=1506 Participants
Region of Enrollment Japan	37 Participants n=1506 Participants
Region of Enrollment Australia	85 Participants n=1506 Participants
Region of Enrollment Austria	11 Participants n=1506 Participants
Region of Enrollment Belgium	27 Participants n=1506 Participants
Region of Enrollment Bulgaria	52 Participants n=1506 Participants
Region of Enrollment France	12 Participants n=1506 Participants
Region of Enrollment Hong Kong	20 Participants n=1506 Participants
Region of Enrollment Ireland	27 Participants n=1506 Participants
Region of Enrollment Italy	61 Participants n=1506 Participants
Region of Enrollment Latvia	11 Participants n=1506 Participants
Region of Enrollment Lithuania	6 Participants n=1506 Participants
Region of Enrollment Malaysia	100 Participants n=1506 Participants
Region of Enrollment Netherlands	50 Participants n=1506 Participants
Region of Enrollment New Zealand	33 Participants n=1506 Participants
Region of Enrollment Norway	2 Participants n=1506 Participants
Region of Enrollment Poland	23 Participants n=1506 Participants
Region of Enrollment Singapore	8 Participants n=1506 Participants
Region of Enrollment Slovakia	92 Participants n=1506 Participants
Region of Enrollment Spain	98 Participants n=1506 Participants
Region of Enrollment Sweden	25 Participants n=1506 Participants
Region of Enrollment Switzerland	12 Participants n=1506 Participants
Region of Enrollment Thailand	1 Participants n=1506 Participants
Region of Enrollment United Kingdom	43 Participants n=1506 Participants
Region of Enrollment South Korea	106 Participants n=1506 Participants

PRIMARY outcome

Timeframe: One Month to one year

Population: The analysis population combines eligible subjects enrolled in the Onyx ONE US \& Japan Trial (NCT03647475) and Onyx ONE Global RCT (NCT03344653) who received the Resolute Onyx stent only, and met the trial definition for one- month clear.

Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction	104 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical method

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Participants With Target Lesion Failure	121 Participants

SECONDARY outcome

Timeframe: Procedure to hospital discharge, an average of 1.3 days

Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Participants With Procedure Success	1295 Participants

SECONDARY outcome

Timeframe: One Month to One Year

All participants deaths including cardiac death

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
All Participants Deaths Including Cardiac Death	89 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Major Cardiac Event	174 Participants

SECONDARY outcome

Timeframe: One Month to One Year

All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Myocardial Infarction	72 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Target Vessel Failure	131 Participants

SECONDARY outcome

Timeframe: One Month to One Year

All revascularizations (TLR, TVR and non-TVR)

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Revascularization	84 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Stent thrombosis (per Academic Research Consortium (ARC) definition)

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Stent Thrombosis	10 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Bleeding per BARC (Bleeding Academic Research Consortium) criteria. This criteria classifies bleeding events with BARC 1 being the least severe and type 5 being the most severe. Grouping of BARC categories: * BARC 3 to 5 - This included all bleeding events in BARC 3 to BARC 5 categories * BARC 2 to 5- This included all bleeding events in BARC 2 to BARC 5 categories * All BARC- This included all bleeding events BARC 1 through BARC 5

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Bleeding All BARC	195 Participants
Number of Patients With Bleeding BARC 3 to 5	60 Participants
Number of Patients With Bleeding BARC 2 to 5	175 Participants

SECONDARY outcome

Timeframe: One Month to One Year

Stroke

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 Participants Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Number of Patients With Stroke	22 Participants

SECONDARY outcome

Timeframe: End of Procedure, an average of 42 minutes

The attainment of \<30% residual stenosis by QCA (or \< 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1960 Lesions Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Lesion Success	1817 Lesions

SECONDARY outcome

Timeframe: End of Procedure an average of 42 minutes

Attainment of \<30% residual stenosis by QCA (or \<20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.

Outcome measures

Outcome measures
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1960 Lesions Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Device Success	1790 Lesions

Adverse Events

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent

Serious events: 591 serious events

Other events: 755 other events

Deaths: 89 deaths

Serious adverse events

Serious adverse events
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 participants at risk Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Blood and lymphatic system disorders Anaemia	2.3% 34/1506 • Number of events 38 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Anaemia Macrocytic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Blood Loss Anaemia	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Coagulopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Febrile Neutropenia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Microcytic Anaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Nephrogenic Anaemia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Normocytic Anaemia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Thrombocytopenia	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Acute Coronary Syndrome	0.53% 8/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Acute Left Ventricular Failure	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Acute Myocardial Infarction	2.5% 38/1506 • Number of events 40 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Angina Pectoris	1.7% 26/1506 • Number of events 26 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Angina Unstable	1.1% 16/1506 • Number of events 16 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Anginal Equivalent	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Aortic Valve Stenosis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Arrhythmia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrial Fibrillation	3.2% 48/1506 • Number of events 59 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrial Flutter	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrial Tachycardia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block Complete	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block First Degree	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block Second Degree	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bradycardia	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bundle Branch Block Left	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bundle Branch Block Right	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Arrest	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Asthma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure	1.4% 21/1506 • Number of events 22 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure Acute	0.53% 8/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure Chronic	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure Congestive	2.7% 40/1506 • Number of events 52 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiogenic Shock	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiomyopathy	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Chronic Left Ventricular Failure	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Conduction Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Artery Disease	0.93% 14/1506 • Number of events 15 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Artery Dissection	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Artery Occlusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Artery Stenosis	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Artery Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Coronary Ostial Stenosis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Dressler's Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Ischaemic Cardiomyopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Left Ventricular Dysfunction	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Microvascular Coronary Artery Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Mitral Valve Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Mitral Valve Incompetence	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Myocardial Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Myocardial Infarction	0.80% 12/1506 • Number of events 12 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Myocardial Ischaemia	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Palpitations	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Pericardial Effusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Prosthetic Cardiac Valve Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Pulseless Electrical Activity	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Sinus Node Dysfunction	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Sinus Tachycardia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Supraventricular Tachycardia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Tachycardia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Ventricular Fibrillation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Ventricular Tachycardia	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Congenital, familial and genetic disorders Gastrointestinal Arteriovenous Malformation	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Congenital, familial and genetic disorders Haemorrhagic Arteriovenous Malformation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Congenital, familial and genetic disorders Hypertrophic Cardiomyopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Deafness	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Vertigo	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Vestibular Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Blindness Unilateral	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Cataract	0.33% 5/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Diabetic Retinopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Eye Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Macular Degeneration	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Retinal Artery Occlusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Retinal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Pain	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Pain Upper	0.13% 2/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Ascites	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Chronic Gastritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Colitis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Colitis Ischaemic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Constipation	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Crohn's Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diarrhoea	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diverticulum	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diverticulum Intestinal Haemorrhagic	0.07% 1/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Dysphagia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Enteritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Erosive Duodenitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Femoral Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Food Poisoning	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastric Perforation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastric Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastritis Erosive	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastrointestinal Erosion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.80% 12/1506 • Number of events 12 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Haematemesis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Haematochezia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Haemorrhagic Ascites	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Haemorrhoids	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Ileus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Impaired Gastric Emptying	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Incarcerated Inguinal Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Inguinal Hernia	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Intra-Abdominal Haematoma	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Large Intestine Polyp	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Levator Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.33% 5/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Melaena	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Mesenteric Artery Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Mouth Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Pancreatitis Acute	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Peptic Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Pharyngo-Oesophageal Diverticulum	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Small Intestinal Obstruction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Tooth Impacted	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Umbilical Hernia	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Umbilical Hernia, Obstructive	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Varices Oesophageal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Adverse Drug Reaction	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Asthenia	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Catheter Site Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Chest Pain	1.1% 17/1506 • Number of events 18 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Death	1.00% 15/1506 • Number of events 15 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Fatigue	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders General Physical Health Deterioration	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Generalised Oedema	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Impaired Healing	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Implant Site Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Incarcerated Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Infusion Site Extravasation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Injection Site Extravasation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Multiple Organ Dysfunction Syndrome	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Non-Cardiac Chest Pain	1.2% 18/1506 • Number of events 19 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Oedema Peripheral	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Peripheral Swelling	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Physical Deconditioning	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Pyrexia	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Sudden Cardiac Death	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Sudden Death	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Vascular Stent Stenosis	1.5% 22/1506 • Number of events 22 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Vascular Stent Thrombosis	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Autoimmune Hepatitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Bile Duct Obstruction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Biliary Colic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholecystitis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholecystitis Acute	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholelithiasis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholestasis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cirrhosis Alcoholic	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Hepatic Cirrhosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Hepatic Mass	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Hepatitis Acute	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Non-Alcoholic Steatohepatitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Immune system disorders Food Allergy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Immune system disorders Hypersensitivity	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Immune system disorders Primary Amyloidosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Abdominal Sepsis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Abscess Jaw	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Abscess Limb	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Arthritis Bacterial	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Bacteraemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Bacterial Parotitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Bronchitis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Bronchitis Viral	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Carbuncle	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Cellulitis	0.53% 8/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Clostridium Difficile Colitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Clostridium Difficile Infection	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Cystitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Cytomegalovirus Oesophagitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Dengue Fever	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Device Related Infection	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Device Related Sepsis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Diabetic Foot Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Diarrhoea Infectious	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Diverticulitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Diverticulitis Intestinal Haemorrhagic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Endocarditis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Endocarditis Bacterial	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Endocarditis Enterococcal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Enterococcal Bacteraemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Enterocolitis Fungal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Escherichia Bacteraemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Gangrene	0.13% 2/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Gastroenteritis	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Gastrointestinal Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Herpes Zoster	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Hordeolum	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Infected Seroma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Infected Skin Ulcer	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Infective Exacerbation Of Chronic Obstructive Airways Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Influenza	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Lower Respiratory Tract Infection	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Nosocomial Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Osteomyelitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Parainfluenzae Virus Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pharyngitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pneumonia	2.9% 43/1506 • Number of events 48 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pneumonia Bacterial	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pneumonia Klebsiella	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Postoperative Wound Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pulmonary Sepsis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pulmonary Tuberculosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pyelonephritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Renal Cyst Infection	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Respiratory Tract Infection	0.33% 5/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Respiratory Tract Infection Viral	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Sepsis	1.00% 15/1506 • Number of events 16 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Septic Shock	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Staphylococcal Bacteraemia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Streptococcal Bacteraemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Tuberculosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Upper Respiratory Tract Infection	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Urinary Tract Infection	1.3% 20/1506 • Number of events 23 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Urinary Tract Infection Bacterial	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Urosepsis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Wound Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Allergic Transfusion Reaction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Anaemia Postoperative	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Ankle Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Arteriovenous Fistula Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Cardiac Procedure Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Cardiac Valve Replacement Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Chemical Peritonitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Costal Cartilage Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Fall	0.13% 2/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Femur Fracture	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Flail Chest	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Haemodialysis Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Hand Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Head Injury	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Hip Fracture	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Humerus Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Incision Site Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Joint Dislocation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Peripheral Artery Restenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Bile Leak	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Postoperative Hypotension	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Postoperative Ileus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Postoperative Thoracic Procedure Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Procedural Dizziness	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Procedural Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Pulmonary Contusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Radius Fracture	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Rib Fracture	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Road Traffic Accident	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Skin Laceration	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Spinal Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Subdural Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Traumatic Intracranial Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Urinary Tract Stoma Complication	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Vascular Access Site Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Wound Dehiscence	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Blood Glucose Fluctuation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Blood Pressure Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Cardiac Output Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Ejection Fraction Decreased	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Haemoglobin Decreased	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Heparin-Induced Thrombocytopenia Test Positive	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Hepatic Enzyme Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Oxygen Saturation Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Pulmonary Function Test Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Stress Echocardiogram Abnormal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Alcoholic Ketoacidosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Dehydration	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Diabetes Mellitus	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Fluid Overload	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Gout	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hypokalaemia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyponatraemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Iron Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Malnutrition	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Mineral Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Vitamin B12 Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Back Pain	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Bursitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Chest Wall Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Flank Pain	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Haematoma Muscle	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Joint Effusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Myositis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Spinal Instability	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Spondylitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Systemic Scleroderma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Trigger Finger	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of Colon	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical Fibroxanthoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.20% 3/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone Cancer Metastatic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm Malignant	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.20% 3/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Adenocarcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Neoplasm	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer Metastatic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal Cancer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip And/Or Oral Cavity Cancer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Carcinoma Cell Type Unspecified Stage Iv	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Central Nervous System	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Malignant Melanoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma Stage Iv	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Adenocarcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Cancer Metastatic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid Tumour Benign	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional Cell Carcinoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Altered State Of Consciousness	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Amputation Stump Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Carotid Artery Occlusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Carotid Artery Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Carpal Tunnel Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cerebral Haemorrhage	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cerebral Infarction	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cerebrovascular Accident	0.66% 10/1506 • Number of events 11 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cerebrovascular Insufficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Dementia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Dizziness	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Embolic Stroke	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Encephalopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Epilepsy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Frontotemporal Dementia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Haemorrhage Intracranial	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Haemorrhagic Stroke	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Headache	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Hemiparesis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Hepatic Encephalopathy	0.20% 3/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Ischaemic Stroke	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Lethargy	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Loss Of Consciousness	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Lumbar Radiculopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Metabolic Encephalopathy	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Myelopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Presyncope	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Sciatica	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Seizure	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Stupor	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Subarachnoid Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Syncope	0.73% 11/1506 • Number of events 12 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Transient Global Amnesia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Transient Ischaemic Attack	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Vertebrobasilar Stroke	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Capturing Issue	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Deposit Issue	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Inappropriate Shock Delivery	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Loosening	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Malfunction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Lead Dislodgement	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Stent Malfunction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.07% 1/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Delirium	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Dissociative Amnesia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Hallucination, Visual	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Mental Status Changes	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Acute Kidney Injury	2.0% 30/1506 • Number of events 34 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Azotaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Calculus Urinary	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Chronic Kidney Disease	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Cystitis Haemorrhagic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Dysuria	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders End Stage Renal Disease	0.40% 6/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Haematuria	0.73% 11/1506 • Number of events 11 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Hydronephrosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Nephrolithiasis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Nephropathy Toxic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Cyst Haemorrhage	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Failure	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Impairment	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Ureterolithiasis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Incontinence	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Retention	0.60% 9/1506 • Number of events 11 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Tract Obstruction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.86% 13/1506 • Number of events 16 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.66% 10/1506 • Number of events 17 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Mediastinal Mass	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.73% 11/1506 • Number of events 11 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.20% 3/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.80% 12/1506 • Number of events 14 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Decubitus Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Diabetic Foot	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Pruritus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Skin Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Urticaria	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Colostomy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Hernia Repair	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Prostatectomy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Toe Operation	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Aortic Aneurysm	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Aortic Dissection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Aortic Stenosis	0.80% 12/1506 • Number of events 12 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Arteriosclerosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Bleeding Varicose Vein	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Deep Vein Thrombosis	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Dry Gangrene	0.13% 2/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Embolism Venous	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Extremity Necrosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Haematoma	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Haemodynamic Instability	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertension	0.60% 9/1506 • Number of events 10 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertensive Crisis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertensive Emergency	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertensive Urgency	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypotension	0.46% 7/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypovolaemic Shock	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Intermittent Claudication	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Orthostatic Hypotension	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Peripheral Arterial Occlusive Disease	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Peripheral Artery Aneurysm	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Peripheral Artery Occlusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Peripheral Ischaemia	0.40% 6/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Peripheral Vascular Disorder	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Steal Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Thrombophlebitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Vena Cava Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.

Other adverse events

Other adverse events
Measure	Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent n=1506 participants at risk Subjects who fulfilled the inclusion criteria and none of the exclusion criteria were treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal was evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population. Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT: To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
Blood and lymphatic system disorders Anaemia	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Anaemia Folate Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Blood Loss Anaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Febrile Neutropenia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Haemorrhagic Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Lymphadenopathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Schistocytosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Blood and lymphatic system disorders Thrombotic Thrombocytopenic Purpura	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Acute Myocardial Infarction	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Angina Pectoris	1.9% 29/1506 • Number of events 32 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Angina Unstable	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Anginal Equivalent	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Arrhythmia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrial Fibrillation	0.93% 14/1506 • Number of events 14 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrial Flutter	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Atrioventricular Block First Degree	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bradycardia	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bundle Branch Block Left	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Bundle Branch Block Right	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure	0.60% 9/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure Chronic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Failure Congestive	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Cardiac Valve Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Defect Conduction Intraventricular	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Intracardiac Thrombus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Mitral Valve Incompetence	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Myocardial Infarction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Palpitations	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Sinus Tachycardia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Cardiac disorders Tricuspid Valve Incompetence	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Congenital, familial and genetic disorders Phimosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Hypoacusis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Vertigo	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Ear and labyrinth disorders Vertigo Positional	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Cataract	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Conjunctival Haemorrhage	0.27% 4/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Diplopia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Eye Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Eye Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Lacrimation Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Eye disorders Vitreous Haemorrhage	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Discomfort	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Pain	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Pain Lower	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Abdominal Pain Upper	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Anal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Anal Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Appendicolith	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Atrophic Glossitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Constipation	0.40% 6/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Dental Caries	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diarrhoea	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diverticulum	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Diverticulum Intestinal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Dyschezia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Dyspepsia	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Dysphagia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastritis	0.20% 3/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gingival Bleeding	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Gingival Hypertrophy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Haematochezia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Inguinal Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Large Intestine Polyp	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Melaena	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Nausea	0.33% 5/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Rectal Haemorrhage	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Tongue Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Tongue Haemorrhage	0.20% 3/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Toothache	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Umbilical Hernia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Gastrointestinal disorders Vomiting	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Adverse Drug Reaction	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Asthenia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Catheter Site Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Catheter Site Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Chest Discomfort	0.60% 9/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Chest Pain	1.9% 28/1506 • Number of events 28 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Drug Intolerance	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Exercise Tolerance Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Fatigue	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Hangover	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Malaise	0.13% 2/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Non-Cardiac Chest Pain	1.4% 21/1506 • Number of events 22 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Oedema Peripheral	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Peripheral Swelling	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Puncture Site Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
General disorders Pyrexia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Biliary Colic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholelithiasis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Cholestasis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Hepatic Lesion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Hepatic Steatosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Hepatobiliary disorders Nonalcoholic Fatty Liver Disease	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Immune system disorders Contrast Media Allergy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Bronchitis	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Cellulitis	0.33% 5/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Chronic Hepatitis C	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Conjunctivitis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Cystitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Ear Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Fungal Skin Infection	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Furuncle	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Gastroenteritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Gastrointestinal Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Helicobacter Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Infected Skin Ulcer	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Influenza	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Lower Respiratory Tract Infection	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Lung Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Nasopharyngitis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Necrotising Soft Tissue Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Oral Candidiasis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Orchitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pharyngitis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pneumonia	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Postoperative Wound Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Pyelonephritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Respiratory Tract Infection	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Rhinitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Tonsillitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Tooth Abscess	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Upper Respiratory Tract Infection	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Urinary Tract Infection	0.66% 10/1506 • Number of events 10 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Viral Upper Respiratory Tract Infection	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Vulvovaginal Candidiasis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Infections and infestations Wound Sepsis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Arteriovenous Fistula Site Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Arteriovenous Graft Site Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Clavicle Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Contusion	1.1% 16/1506 • Number of events 19 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Eye Injury	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Fall	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Femur Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Head Injury	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Humerus Fracture	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Incision Site Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Ligament Sprain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Limb Injury	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Muscle Injury	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Muscle Strain	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Patella Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Periorbital Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Plaque Shift	0.07% 1/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Haematuria	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Postoperative Hypertension	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Rib Fracture	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Skin Abrasion	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Skin Injury	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Skin Laceration	0.66% 10/1506 • Number of events 10 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Subdural Haematoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Tooth Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Toxicity To Various Agents	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Traumatic Haematoma	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Upper Limb Fracture	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Vascular Access Site Bruising	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Vascular Access Site Haematoma	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Vascular Access Site Haemorrhage	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Vascular Access Site Pseudoaneurysm	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Wound	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Injury, poisoning and procedural complications Wound Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Aortic Bruit	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Blood Creatinine Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Blood Pressure Increased	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Haemoglobin Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations International Normalised Ratio Abnormal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Liver Function Test Abnormal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Nutritional Condition Normal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Occult Blood	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Occult Blood Positive	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Troponin Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Venous Pressure Jugular Increased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Investigations Vitamin B12 Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Calcium Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Decreased Appetite	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Diabetes Mellitus	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Electrolyte Imbalance	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Fluid Overload	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Gout	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hyperuricaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hypoglycaemia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Hypomagnesaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Iron Deficiency	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Metabolism and nutrition disorders Vitamin D Deficiency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.73% 11/1506 • Number of events 11 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Back Pain	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Chondrocalcinosis Pyrophosphate	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Joint Effusion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Joint Swelling	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Mobility Decreased	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.46% 7/1506 • Number of events 7 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Neck Mass	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Osteoporosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Pain In Jaw	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Sarcopenia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Musculoskeletal and connective tissue disorders Sjogren's Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myolipoma	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma Of Skin	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Akinesia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Amnesia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Balance Disorder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Carotid Artery Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cerebral Ischaemia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Cognitive Disorder	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Corticobasal Degeneration	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Dizziness	0.53% 8/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Focal Dyscognitive Seizures	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Headache	0.53% 8/1506 • Number of events 9 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Hypoaesthesia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Hypotonia	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Migraine	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Polyneuropathy	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Sciatica	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Syncope	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Tension Headache	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Tonic Convulsion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Transient Ischaemic Attack	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Nervous system disorders Visual Field Defect	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Product Issues Device Malfunction	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Confusional State	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Delirium	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Depression	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Insomnia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Psychiatric disorders Psychotic Disorder Due To A General Medical Condition	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Acute Kidney Injury	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Bladder Dilatation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Calculus Bladder	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Chronic Kidney Disease	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Dysuria	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Haematuria	1.4% 21/1506 • Number of events 22 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Nocturia	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Pollakiuria	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Failure	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Impairment	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Renal Mass	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urethral Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urethral Perforation	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Bladder Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Incontinence	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urinary Retention	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Renal and urinary disorders Urogenital Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Reproductive system and breast disorders Adnexa Uteri Mass	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Reproductive system and breast disorders Vaginal Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Apnoea	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Asthma	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Cough	0.33% 5/1506 • Number of events 5 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.93% 14/1506 • Number of events 17 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.3% 20/1506 • Number of events 23 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Nasal Crusting	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Nocturnal Dyspnoea	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Respiratory, thoracic and mediastinal disorders Upper-Airway Cough Syndrome	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Dermal Cyst	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Dermatitis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Ecchymosis	0.53% 8/1506 • Number of events 8 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Eczema	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Ingrowing Nail	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Nail Bed Bleeding	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Petechiae	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Rash	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Skin Lesion	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Skin Necrosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Skin Ulcer Haemorrhage	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Skin and subcutaneous tissue disorders Spider Naevus	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Cerumen Removal	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Surgical and medical procedures Skin Neoplasm Excision	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Aortic Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Deep Vein Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Extremity Necrosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Haematoma	0.40% 6/1506 • Number of events 6 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertension	0.66% 10/1506 • Number of events 12 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertensive Crisis	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypertensive Emergency	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Hypotension	0.27% 4/1506 • Number of events 4 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Intermittent Claudication	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Jugular Vein Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Labile Blood Pressure	0.13% 2/1506 • Number of events 2 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Orthostatic Hypotension	0.20% 3/1506 • Number of events 3 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Subclavian Vein Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Thrombophlebitis Superficial	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Varicose Vein Ruptured	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Venous Stenosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.
Vascular disorders Venous Thrombosis	0.07% 1/1506 • Number of events 1 • From One Month to 365 Days For the purpose of this clinical investigation, reportable events ( Subjects enrolled in NCT03344653 and those enrolling in Japan were required to report all AEs per local regulations) in the subject population being evaluated were those that met the criteria for a Serious Adverse Event (SAE) and any AE related to the trial end points, including all bleeding events. For the purposes of the primary endpoint evaluation, events assessed from one month to 365 days were included in the analysis.

Additional Information

Cecile Mahoney, Sr. Clinical Research Specialist

Medtronic Coronary/Renal Denervation (C/RDN)

Phone: 763-505-1057

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place