Explore the Efficacy and Safety of Once-daily Oral Rivaro... | NCT01674647

NCT01674647

ID	Type	Description	Link
2011-002234-39	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban (Xarelto, BAY59-7939)	Experimental	A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. Rivaroxaban will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with rivaroxaban will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. Rivaroxaban will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.	Drug: Rivaroxaban (Xarelto, BAY59-7939)
Vitamin K antagonist (VKA)	Active Comparator	A Direct Cardioversion Strategy can be performed only if sufficient anticoagulation is proven during the last 21 days prior to randomization and/or a transesophageal echocardiogram (TEE) is planned before cardioversion. VKA will be given for 1-5 days before planned direct cardioversion. The run-in of 1-5 days is needed due to potential pretreatment with VKA. Treatment with VKA will be continued for 42 days after the cardioversion. A Delayed Cardioversion Strategy will be chosen if sufficient anticoagulation is not proven during the last 21 days prior to randomization and no TEE is planned. VKA will be given for at least 21 (+4) days before the planned cardioversion, to a maximum of 56 (+4) days prior to planned cardioversion.	Drug: Vitamin K antagonist (VKA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (Xarelto, BAY59-7939)	Drug	Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death	Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.	From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment
Number of Participants With Major Bleedings as Per Central Adjudication	Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.	From randomization up to the date of the last dose of study drug + 2 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms	Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men or women aged >= 18 years
Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

Severe, disabling stroke (modified Rankin score of 4- 5, inclusive) within 3 months or any stroke within 14 days prior to randomization
Transient ischemic attack within 3 days prior to randomization
Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
Acute Myocardial infarction (MI) within the last 14 days prior to randomization
Cardiac-related criteria: known presence of cardiac thombus or myxoma or valvular atrial fibrillation
Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Concomitant medications: indication for anticoagulant therapy other than atrial fibrillation, chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy, strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp) if used systemically
Concomitant conditions: childbearing potential without proper contraceptive measures, pregnancy, or breast feeding; hypersensitivity to investigational treatment or comparator treatment; calculated creatinine clearance (CrCl) < 30 mL/minute; hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk; any severe condition that would limit life expectancy to less than 6 months; planned invasive procedure with potential for uncontrolled bleeding; inability to take oral medication; ongoing drug addiction or alcohol abuse
Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
Participation in a study with an investigational drug or medical device within 30 days prior to randomization

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25182247	Background	Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.
24944325

Label	URL
Click here to find information about studies related to Bayer Healthcare products conducted in Europe	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
BG001	Vitamin K Antagonist (VKA)	Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.9± 10.6 BG00164.7± 10.5 BG00264.9± 10.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000275 BG001135 BG002

CHADS 2 score

Predicts clinical risk of stroke and thromboembolism in atrial fibrillation incorporating these risk factors: Congestive heart failure, Hypertension, Age [greater than or equal to (>=)75 years], Diabetes mellitus, Stroke/transient ischemic attack. Total score ranged from 0 to 6, with "0"= low risk, "1"= moderate risk and ">=2"= high risk.

Mean

Standard Deviation

units on scale

Title

Denominators

Categories

Title	Measurements
	BG0001.3± 1.1 BG001

CHA 2 DS 2 VASc score

Predicts clinical risk of stroke and thromboembolism in atrial fibrillation incorporating these risk factors: Congestive heart failure/left ventricular dysfunction, Hypertension, Age >= 75 years, Diabetes mellitus, Stroke/transient ischemic attack/thromboembolism, Vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque), Age 65 - 74 years, Sex category (i.e., female). Total score ranged from 0 to 8, with "0" (or 1 if female only)= Low risk ; "1" (except for female gender alone)= moderate risk and ">=2"=high risk.

Mean

Standard Deviation

units on scale

Title

Denominators

Categories

Title	Measurements
	BG0002.3± 1.6 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death

Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.

The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study.

Posted

Number

Participants

From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
OG001	Vitamin K Antagonist (VKA)	Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.

Units	Counts
Participants	OG000978 OG001492

Title

Denominators

Categories

Title	Measurements
	OG0005 OG0015

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Descriptive comparison of crude estimates of the cumulative incidence and estimation of risk ratio, all with 95% confidence intervals	no statistical test performed				Risk Ratio (RR)	0.50			2-Sided	95	0.15	1.73			Crude estimate of the cumulative incidence for rivaroxaban (Xarelto, BAY59-7939): 0.51% (0.20% - 1.17%). Crude estimate of the cumulative incidence for Vitamin K antagonist (VKA): 1.02% (0.40% - 2.34%).	No	Superiority or Other

Primary

Number of Participants With Major Bleedings as Per Central Adjudication

Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.

The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication.

Posted

Number

Participants

From randomization up to the date of the last dose of study drug + 2 days

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms

Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.

The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality

Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Strokes

All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Transient Ischemic Attacks

All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Non-central Nervous System Systemic Embolisms

All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Myocardial Infarctions

All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Cardiovascular Deaths

All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With All-cause Mortality

All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.

Posted

Number

Participants

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Secondary

Number of Participants With Composite of Major and Non-major Bleeding Events

All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.

The safety profile was analyzed using the SAF population. SAF population included all randomized subjects who received at least 1 dose of study medication.

Posted

Number

Participants

From randomization up to the date of the last dose of study drug + 2 days

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban (Xarelto; BAY59-7939)	Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.			93	988	272	988
EG001	Vitamin K Antagonist	Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.			38	499	126	499

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Angina pectoris	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0010 affected499 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0008 affected988 at risk EG0014 affected499 at risk
Atrial flutter	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0004 affected988 at risk EG0011 affected499 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0004 affected988 at risk EG0013 affected499 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Bradycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0013 affected499 at risk
Cardiac arrest	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0010 affected499 at risk
Cardiac failure	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0008 affected988 at risk EG0012 affected499 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG00010 affected988 at risk EG0012 affected499 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Coronary artery disease	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0010 affected499 at risk
Pericardial effusion	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Rhythm idioventricular	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0012 affected499 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0012 affected499 at risk
Tachycardia induced cardiomyopathy	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Blindness transient	Eye disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0004 affected988 at risk EG0010 affected499 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0011 affected499 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0010 affected499 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0010 affected499 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0012 affected499 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Chest discomfort	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0011 affected499 at risk
Chest pain	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG0005 affected988 at risk EG0010 affected499 at risk
Medical device site reaction	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Non-cardiac chest pain	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Bronchitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0011 affected499 at risk
Bronchitis viral	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Cellulitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0011 affected499 at risk
Diverticulitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Gastroenteritis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Pharyngitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Pneumonia	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0013 affected499 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Urinary tract infection	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Arteriogram coronary	Investigations	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Liver function test abnormal	Investigations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Dizziness	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Presyncope	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Syncope	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0010 affected499 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Delirium	Psychiatric disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Haematuria	Renal and urinary disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0012 affected499 at risk
Urogenital haemorrhage	Renal and urinary disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0004 affected988 at risk EG0011 affected499 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Bladder catheterisation	Surgical and medical procedures	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0011 affected499 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Plastic surgery	Surgical and medical procedures	MedDRA (16.1)	Non-systematic Assessment	EG0000 affected988 at risk EG0011 affected499 at risk
Shoulder arthroplasty	Surgical and medical procedures	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0010 affected499 at risk
Hypotension	Vascular disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0010 affected499 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG0002 affected988 at risk EG0017 affected499 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG00016 affected988 at risk EG0016 affected499 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG00040 affected988 at risk EG00125 affected499 at risk
Bradycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG00030 affected988 at risk EG00113 affected499 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (16.1)	Non-systematic Assessment	EG00025 affected988 at risk EG00112 affected499 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00010 affected988 at risk EG0013 affected499 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00018 affected988 at risk EG0013 affected499 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00017 affected988 at risk EG0011 affected499 at risk
Fatigue	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG00014 affected988 at risk EG0019 affected499 at risk
Oedema peripheral	General disorders	MedDRA (16.1)	Non-systematic Assessment	EG00020 affected988 at risk EG0015 affected499 at risk
Influenza	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0015 affected499 at risk
Nasopharyngitis	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG00012 affected988 at risk EG0015 affected499 at risk
Urinary tract infection	Infections and infestations	MedDRA (16.1)	Non-systematic Assessment	EG0007 affected988 at risk EG0015 affected499 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Non-systematic Assessment	EG0003 affected988 at risk EG0015 affected499 at risk
International normalised ratio increased	Investigations	MedDRA (16.1)	Non-systematic Assessment	EG0001 affected988 at risk EG0019 affected499 at risk
Dizziness	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG00025 affected988 at risk EG0019 affected499 at risk
Headache	Nervous system disorders	MedDRA (16.1)	Non-systematic Assessment	EG00025 affected988 at risk EG0017 affected499 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00013 affected988 at risk EG0013 affected499 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00016 affected988 at risk EG00112 affected499 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Non-systematic Assessment	EG00030 affected988 at risk EG0019 affected499 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.1)	Non-systematic Assessment	EG00012 affected988 at risk EG0015 affected499 at risk
Hypertension	Vascular disorders	MedDRA (16.1)	Non-systematic Assessment	EG00022 affected988 at risk EG0014 affected499 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36608	United States

ID	Term
D001281	Atrial Fibrillation
D020521	Stroke
D002546	Ischemic Attack, Transient
D013923	Thromboembolism

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002545	Brain Ischemia
D016769	Embolism and Thrombosis

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds