Study Of The Blood Thinner, Apixaban, For Patients Who Ha... | NCT02100228

NCT02100228

ID	Type	Description
CV185-267	Other Identifier	Alias Study Number
2014-001231-36	EudraCT Number
EMANATE	Other Identifier	Alias Study Number

Status Module

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

Label	Type	Description	Intervention Names
Apixaban	Experimental		Drug: Apixaban
Parenteral heparin and/or oral Vitamin K antagonist	Active Comparator	Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)	Drug: Parenteral heparin and/or oral Vitamin K antagonist

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug	Oral, 2.5 or 5 mg BID	Apixaban
Parenteral heparin and/or oral Vitamin K antagonist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Acute Stroke Event	An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Number of Participants With Systemic Embolism Event	Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Number of Participants With Major Bleeding Event	Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.	Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
Number of Participants With Clinically Relevant Non-Major Bleeding Events	Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.

Secondary Outcomes

Measure	Description	Time Frame
Time to First Attempt of Cardioversion	Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.	Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram (ECG) at Visit 1) indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label. Subjects presenting with atrial flutter with no evidence of atrial fibrillation are not eligible for enrolment.
Age ≥18 years (Age ≥ 19 years for Korea only and Age ≥ 20 years for Japan only).
Evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
The subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study. (Subject to IRB/IEC approval)
Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.

Exclusion Criteria:

Subjects having taken more than 48 hours of an anticoagulant (oral and/or parenteral) immediately prior to randomization.
Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label.
Severe haemodynamically compromised subjects requiring emergent cardioversion.
Patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic heart valve).
Simultaneous treatment with both aspirin and a thienopyridine (eg, clopidogrel, ticlopidine, prasugrel) or simultaneous treatment with both aspirin and ticagrelor.
Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Note: Subjects cannot be randomized into this study more than once.
Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are BMS/Pfizer employees directly involved in the conduct of the trial.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Brookwood Medical Center		Birmingham	Alabama	35209	United States
Cardiovascular Associates of the Southeast, LLC

PubMed Identifier	Type	Citation	Retractions
29659797	Derived	Ezekowitz MD, Pollack CV Jr, Halperin JL, England RD, VanPelt Nguyen S, Spahr J, Sudworth M, Cater NB, Breazna A, Oldgren J, Kirchhof P. Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial. Eur Heart J. 2018 Aug 21;39(32):2959-2971. doi: 10.1093/eurheartj/ehy148.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Feb 2, 2017	Jan 17, 2018

Arm/Group Information

ID	Title	Description
BG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
BG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.
BG002	Total	Total of all reporting groups

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 Acute Stroke Event

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

Full analysis set included all randomized participants.

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Units	Counts
Participants	OG000753 OG001747

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0016

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	Display exact confidence limits for relative risk and Fisher's exact test for comparisons of two proportions.	Fisher Exact		0.0151	nominal p-value	Risk Ratio (RR)	0.0000			2-Sided	95	0.0000	0.6425					Superiority	This was a descriptive study, and there was no formal pre-defined hypothesis testing.

Primary

Number of Participants With Systemic Embolism Event

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

Full analysis set included all randomized participants.

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Primary

Number of Participants With Major Bleeding Event

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

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

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Primary

Number of Participants With Clinically Relevant Non-Major Bleeding Events

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

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

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001

Primary

Number of Participants With All Cause Death

Full analysis set included all randomized participants.

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Units	Counts
Participants

Secondary

Time to First Attempt of Cardioversion

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

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

Posted

Median

Full Range

days

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Secondary

Number of Participants With Different Type of Cardioversion Events

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

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

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Secondary

Number of Cardioversion Attempt of Participants

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

Full analysis set included all randomized participants.

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Secondary

Number of Participants With Their Rhythm Status

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

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

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Secondary

Duration of Hospital Stay of Participants

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

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

Posted

Median

Full Range

hours

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

Secondary

Number of Participants Who Used Image Guidance Approach

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

Full analysis set included all randomized participants.

Posted

Number

participants

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

ID	Title	Description
OG000	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.
OG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.

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	Apixaban	Participants with non-valvular atrial fibrillation undergoing cardioversion, received Apixaban orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of Apixaban was based on investigator's judgement as per local label for the prevention of stroke and systemic embolism in participants.	1	735	100	735	70	735
EG001	Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care)	Participants with non-valvular atrial fibrillation undergoing cardioversion, received parenteral heparin and/or oral Vitamin K antagonist as usual care, orally for 30 days after cardioversion or 90 days after randomization if cardioversion was not performed. The dosing of the parenteral heparin and Vitamin K antagonist was based on individual participant's sensitivity to the drug according to the investigators usual practice.	3	721	112	721	101	721

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG00027 affected735 at risk EG00140 affected721 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected735 at risk EG0016 affected721 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0013 affected721 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ATRIOVENTRICULAR DISSOCIATION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0005 affected735 at risk EG0017 affected721 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0009 affected735 at risk EG0017 affected721 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0016 affected721 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
MITRAL VALVE PROLAPSE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0013 affected721 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PALPITATIONS	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PERICARDITIS CONSTRICTIVE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
SINUS ARREST	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0011 affected721 at risk
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0011 affected721 at risk
TACHYARRHYTHMIA	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
TACHYCARDIA INDUCED CARDIOMYOPATHY	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
TRICUSPID VALVE INCOMPETENCE	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ADENOMATOUS POLYPOSIS COLI	Congenital, familial and genetic disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
HYPERTROPHIC CARDIOMYOPATHY	Congenital, familial and genetic disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
ADRENAL HAEMORRHAGE	Endocrine disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
TOXIC NODULAR GOITRE	Endocrine disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
FEMORAL HERNIA INCARCERATED	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0011 affected721 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
MELAENA	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
MESENTERIC PANNICULITIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
OEDEMATOUS PANCREATITIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
PEPTIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ASTHENIA	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
CHEST PAIN	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
HERNIA	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
MUCOSAL HAEMORRHAGE	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected735 at risk EG0010 affected721 at risk
SUDDEN DEATH	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
DRUG-INDUCED LIVER INJURY	Hepatobiliary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
HEPATIC CONGESTION	Hepatobiliary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
BRONCHITIS	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
CELLULITIS	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
INFECTION	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
INFLUENZA	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
INTESTINAL SEPSIS	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
LUNG INFECTION	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
PNEUMONIA	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0003 affected735 at risk EG0015 affected721 at risk
SEPSIS	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
UROSEPSIS	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ARTERIAL BYPASS THROMBOSIS	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
EYE INJURY	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0010 affected721 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0013 affected721 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
TRAUMATIC INTRACRANIAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
COMPUTERISED TOMOGRAM CORONARY ARTERY ABNORMAL	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
FUNCTIONAL RESIDUAL CAPACITY DECREASED	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
INTERNATIONAL NORMALISED RATIO ABNORMAL	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
WEIGHT DECREASED	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ACUTE LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
BRAIN INJURY	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0013 affected721 at risk
DEMENTIA	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
DIZZINESS	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
SEIZURE	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
SYNCOPE	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0012 affected721 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0012 affected721 at risk
DEPRESSION	Psychiatric disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0015 affected721 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
POSTRENAL FAILURE	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0011 affected721 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected735 at risk EG0010 affected721 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
MEDIASTINAL CYST	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
MEDIASTINAL HAEMATOMA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 affected735 at risk EG0011 affected721 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 affected735 at risk EG0010 affected721 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0012 affected721 at risk
PULMONARY SARCOIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
SUBCUTANEOUS EMPHYSEMA	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
HAEMATOMA	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0011 affected721 at risk
HYPERTENSION	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG0012 affected721 at risk
HYPOTENSION	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 affected735 at risk EG0010 affected721 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG00043 affected735 at risk EG00146 affected721 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG00017 affected735 at risk EG00113 affected721 at risk
INTERNATIONAL NORMALISED RATIO ABNORMAL	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG00119 affected721 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 affected735 at risk EG00127 affected721 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00015 affected735 at risk EG0018 affected721 at risk

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms