A Study Exploring Two Strategies of Rivaroxaban (JNJ39039... | NCT01830543

NCT01830543

ID	Type	Description	Link
RIVAROXAFL3003	Other Identifier	Janssen Scientific Affairs, LLC
2012-001491-11	EudraCT Number

Status Module

Name	Class
Bayer	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rivaroxaban 2.5 mg twice daily	Experimental	rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months	Drug: rivaroxaban 2.5 mg Drug: rivaroxaban 15 mg Drug: rivaroxaban 10 mg Drug: aspirin (ASA) Drug: clopidogrel Drug: prasugrel Drug: ticagrelor
vitamin K antagonist (VKA)	Experimental	dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months	Drug: aspirin (ASA) Drug: vitamin K antagonist (VKA) Drug: clopidogrel Drug: prasugrel Drug: ticagrelor
rivaroxaban 15 mg once daily	Experimental	rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months	Drug: rivaroxaban 15 mg Drug: rivaroxaban 10 mg Drug: clopidogrel Drug: prasugrel Drug: ticagrelor

Name	Type	Description	Arm Group Labels	Other Names
rivaroxaban 2.5 mg	Drug	One 2.5 mg tablet twice daily for up to twelve months	rivaroxaban 2.5 mg twice daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Clinically Significant Bleeding	Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.	Up to Month 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding	TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).	Up to Month 12 and end of DAPT-Month 1, 6 and 12

Eligibility Module

Name	Affiliation	Role
Janssen Scientific Affairs, LLC Clinical Trial	Janssen Scientific Affairs, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31707805	Derived	Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial. Circ Cardiovasc Interv. 2019 Nov;12(11):e008160. doi: 10.1161/CIRCINTERVENTIONS.119.008160. Epub 2019 Nov 11.
31535314

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
BG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
BG002	Vitamin K Antagonist (VKA)	Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.](streamdown:incomplete-link)
BG003	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
	BG00070.4± 9.12 BG00170± 9.11 BG00269.9± 8.67 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000181 BG001174 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG00032 BG00127 BG002

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

Percentage of Participants With Clinically Significant Bleeding

Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.

The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Up to Month 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
OG002	Vitamin K Antagonist (VKA)	Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.](streamdown:incomplete-link)

Units	Counts
Participants	OG000696 OG001706 OG002697

Title

Denominators

Categories

Title	Measurements
	OG00015.7 OG00116.6 OG00224.0

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 OG002		Log Rank		<0.001		Hazard Ratio (HR)	0.59			2-Sided	95	0.47	0.76					Superiority or Other
OG001 OG002		Log Rank		<0.001

Secondary

Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).

The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding

TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).

The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)

A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)

Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.

The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Cardiovascular Death

The percentage of participants with the first occurrence of cardiovascular death were evaluated.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Myocardial Infarction

The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Stroke

The percentage of participants with the first occurrence of Stroke were evaluated.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Secondary

Percentage of Participants With Stent Thrombosis

The percentage of participants with the first occurrence of stent thrombosis were evaluated.

Posted

Number

percentage of participants

Up to Month 12 and end of DAPT-Month 1, 6 and 12

ID	Title	Description
OG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
OG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban 15 mg	Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.	237	696	174	696
EG001	Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)	Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.	225	706	210	706
EG002	Vitamin K Antagonist (VKA)	Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.](streamdown:incomplete-link)	271	697	234	697

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0014 affected706 at risk EG0024 affected697 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Hypergammaglobulinaemia	Blood and lymphatic system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Microcytic Anaemia	Blood and lymphatic system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0015 affected706 at risk EG0023 affected697 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0007 affected696 at risk EG00113 affected706 at risk EG00215 affected697 at risk
Angina Unstable	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00016 affected696 at risk EG00112 affected706 at risk EG00223 affected697 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00013 affected696 at risk EG00121 affected706 at risk EG00223 affected697 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0015 affected706 at risk EG0024 affected697 at risk
Atrial Tachycardia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Atrial Thrombosis	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0004 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Atrioventricular Block	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bradycardia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0022 affected697 at risk
Cardiac Disorder	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00021 affected696 at risk EG00116 affected706 at risk EG00231 affected697 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0013 affected706 at risk EG0024 affected697 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0007 affected696 at risk EG0014 affected706 at risk EG00211 affected697 at risk
Cardiac Pseudoaneurysm	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cardiovascular Disorder	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0015 affected706 at risk EG0022 affected697 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Coronary Artery Thrombosis	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Dressler's Syndrome	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Left Ventricular Dysfunction	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Myocardial Infarction	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Palpitations	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Pericardial Effusion	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Pericardial Haemorrhage	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pericarditis	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Sinus Node Dysfunction	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0004 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Tachycardia Induced Cardiomyopathy	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Ventricular Arrhythmia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Ventricular Fibrillation	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Deafness Neurosensory	Ear and labyrinth disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Age-Related Macular Degeneration	Eye disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cataract	Eye disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0023 affected697 at risk
Eye Haemorrhage	Eye disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Vitreous Haemorrhage	Eye disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Anal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Barrett's Oesophagus	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Change of Bowel Habit	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Colitis Microscopic	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Faecaloma	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gastric Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Gastric Mucosa Erythema	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0013 affected706 at risk EG0023 affected697 at risk
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0022 affected697 at risk
Gastritis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Gastroduodenitis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0007 affected696 at risk EG0017 affected706 at risk EG0029 affected697 at risk
Gastrointestinal Ulcer	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Haematemesis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Haematochezia	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Intestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Intra-Abdominal Haematoma	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Mallory-Weiss Syndrome	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Melaena	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0024 affected697 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0004 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Stomatitis	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Tongue Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Catheter Site Swelling	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Chest Discomfort	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Chest Pain	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0008 affected696 at risk EG0014 affected706 at risk EG0029 affected697 at risk
Death	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Device Failure	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Drug Intolerance	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Drug Resistance	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Fatigue	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Gait Disturbance	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Malaise	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Medical Device Complication	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Multi-Organ Failure	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Oedema Peripheral	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pyrexia	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Sudden Cardiac Death	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Sudden Death	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Ulcer Haemorrhage	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Vascular Stent Occlusion	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Vascular Stent Restenosis	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Vascular Stent Thrombosis	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0023 affected697 at risk
Hepatic Cyst	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hepatitis Acute	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hepatitis Toxic	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hepatocellular Injury	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Jaundice	Hepatobiliary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Anaphylactic Shock	Immune system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Abdominal Wall Abscess	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Abscess Limb	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Appendicitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Arthritis Bacterial	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Bacterial Sepsis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bronchitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Bronchitis Bacterial	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cellulitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cystitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Diverticulitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Encephalitis Viral	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Epididymitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Erysipelas	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gangrene	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Haematoma Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Herpes Zoster	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Infective Exacerbation of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Influenza	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Intervertebral Discitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Liver Abscess	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Localised Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Periodontitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Pneumonia	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG00012 affected696 at risk EG00112 affected706 at risk EG00214 affected697 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Scrotal Abscess	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Sepsis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Septic Shock	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Tracheitis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Tuberculosis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0012 affected706 at risk EG0023 affected697 at risk
Urosepsis	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Compression Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Muscle Rupture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0016 affected706 at risk EG0027 affected697 at risk
Pneumothorax Traumatic	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Post Procedural Complication	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Pubis Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Subdural Haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Traumatic Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Biopsy Prostate	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cardiac Stress Test	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Ejection Fraction Decreased	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Electrocardiogram Ambulatory Abnormal	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Haemoglobin Decreased	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Hepatic Enzyme Increased	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
International Normalised Ratio Increased	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0024 affected697 at risk
Lipids Increased	Investigations	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Diabetic Metabolic Decompensation	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Metabolic Disorder	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gouty Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Musculoskeletal Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Rheumatic Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Spinal Disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Spinal Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Adrenal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Ameloblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bladder Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Brain Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Breast Cancer Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bronchial Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Colon Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Colorectal Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Diffuse Large B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Gallbladder Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Gastrointestinal Stromal Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Metastases to Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pituitary Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Rectal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Small Cell Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Aphasia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0024 affected697 at risk
Cerebral Infarction	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0014 affected706 at risk EG0020 affected697 at risk
Dizziness	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Dizziness Postural	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Epilepsy	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Haemorrhagic Stroke	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Hemianopia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hemiparesis	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Intercostal Neuralgia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Intracranial Haematoma	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0012 affected706 at risk EG0024 affected697 at risk
Lacunar Infarction	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Neuralgia	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Parkinson's Disease	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Presyncope	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Sciatica	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Syncope	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0014 affected706 at risk EG0028 affected697 at risk
Tension Headache	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Viith Nerve Paralysis	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Anxiety	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Anxiety Disorder	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Confusional State	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Delirium	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Depression	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Hallucination	Psychiatric disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Bladder Tamponade	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Calculus Urethral	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0013 affected706 at risk EG0024 affected697 at risk
Haemorrhage Urinary Tract	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Prerenal Failure	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Urethral Haemorrhage	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Cervical Polyp	Reproductive system and breast disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0012 affected706 at risk EG0023 affected697 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0006 affected696 at risk EG0016 affected706 at risk EG00210 affected697 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0023 affected697 at risk
Dyspnoea at Rest	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0005 affected696 at risk EG0015 affected706 at risk EG0025 affected697 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0012 affected706 at risk EG0024 affected697 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0011 affected706 at risk EG0022 affected697 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Angioplasty	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Aortic Valve Replacement	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Cardiac Ablation	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Cardiac Pacemaker Insertion	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Cardiac Resynchronisation Therapy	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Cardioversion	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Coronary Arterial Stent Insertion	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Coronary Artery Bypass	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Hospitalisation	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Ileostomy Closure	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Implantable Defibrillator Insertion	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Mitral Valve Repair	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Percutaneous Coronary Intervention	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Renal Sympathetic Nerve Ablation	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Tooth Extraction	Surgical and medical procedures	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Aortic Aneurysm	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Aortic Stenosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Arterial Stenosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Arteriosclerosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Arteriovenous Fistula	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Circulatory Collapse	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Extremity Necrosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Haematoma	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0023 affected697 at risk
Haemorrhage	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0021 affected697 at risk
Hypertension	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0003 affected696 at risk EG0012 affected706 at risk EG0022 affected697 at risk
Hypertensive Crisis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0013 affected706 at risk EG0022 affected697 at risk
Hypotension	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Intermittent Claudication	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0012 affected706 at risk EG0020 affected697 at risk
Lymphocele	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Malignant Hypertension	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0004 affected696 at risk EG0010 affected706 at risk EG0022 affected697 at risk
Peripheral Artery Thrombosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Peripheral Embolism	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0012 affected706 at risk EG0021 affected697 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0010 affected706 at risk EG0021 affected697 at risk
Venous Occlusion	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0001 affected696 at risk EG0010 affected706 at risk EG0020 affected697 at risk
Venous Thrombosis	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0000 affected696 at risk EG0011 affected706 at risk EG0020 affected697 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00013 affected696 at risk EG00118 affected706 at risk EG00212 affected697 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00012 affected696 at risk EG00118 affected706 at risk EG00211 affected697 at risk
Gingival Bleeding	Gastrointestinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00017 affected696 at risk EG00116 affected706 at risk EG00218 affected697 at risk
Oedema Peripheral	General disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00014 affected696 at risk EG00112 affected706 at risk EG00218 affected697 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG00013 affected696 at risk EG00135 affected706 at risk EG00225 affected697 at risk
Subcutaneous Haematoma	Injury, poisoning and procedural complications	MedDRA Version 18.1	Non-systematic Assessment	EG0002 affected696 at risk EG00110 affected706 at risk EG00214 affected697 at risk
Dizziness	Nervous system disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0008 affected696 at risk EG0017 affected706 at risk EG00215 affected697 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00018 affected696 at risk EG00114 affected706 at risk EG00214 affected697 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00027 affected696 at risk EG00121 affected706 at risk EG00218 affected697 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00067 affected696 at risk EG00159 affected706 at risk EG00282 affected697 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA Version 18.1	Non-systematic Assessment	EG0004 affected696 at risk EG00116 affected706 at risk EG00215 affected697 at risk
Haematoma	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00021 affected696 at risk EG00131 affected706 at risk EG00261 affected697 at risk
Hypertension	Vascular disorders	MedDRA Version 18.1	Non-systematic Assessment	EG00017 affected696 at risk EG0012 affected706 at risk EG0027 affected697 at risk

Certain Agreements

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013988	Ticlopidine
D058924	Thienopyridines
D011725	Pyridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D010879	Piperazines
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

Facility	Status	City	State	ZIP	Country	Contacts
		Huntsville	Alabama		United States

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

ID	Term
D000069552	Rivaroxaban
D001241	Aspirin
C008208	acarboxyprothrombin
D000077144	Clopidogrel
D000068799	Prasugrel Hydrochloride
D000077486	Ticagrelor