Global Study Comparing a rivAroxaban-based Antithrombotic... | NCT02556203

NCT02556203

ID	Type	Description	Link
2015-001975-30	EudraCT Number

Status Module

Name	Class
Janssen Research & Development, LLC	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 (Xarelto, BAY59-7939)	Experimental	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Acetylsalicylic Acid (ASA)
Antiplatelet	Active Comparator	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.	Drug: Acetylsalicylic Acid (ASA) Drug: Clopidogrel Drug: Vitamin K antagonist (VKA)

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (Xarelto, BAY59-7939)	Drug	10mg OD (once-daily)	Rivaroxaban (Xarelto, BAY59-7939)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Death or First Thromboembolic Event (DTE)	Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.	Through study completion, on average 14 months
Number of Participants With Death or First Thromboembolic Event (DTE)	Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.	Through study completion, on average 16 months
Number of Participants With Primary Bleeding Event (PBE)	PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.	Through study completion, on average 16 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Net-clinical Benefit	The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).	Through study completion, on average 16 months

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90048-0750	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36040717	Derived	Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchetche D, Mollmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Wohrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.
35934563

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 17, 2016	Nov 21, 2019

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
BG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00080.38± 7.12 BG00180.77± 5.99 BG00280.57± 6.58

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000400 BG001413 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00026 BG00117 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 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

Number of Participants With Death or First Thromboembolic Event (DTE)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.

Safety analysis set (SAF): Included all randomized subjects who had been exposed to study drug at least once (1608 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 14 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Units	Counts
Participants	OG000801 OG001807

Title

Denominators

Categories

Title	Measurements
	OG00068 OG00163

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	H0: HR(t)>=1.20 for all time points t>=0, (i.e. "the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group")					Hazard Ratio (HR)	1.2089302			1-Sided	97.5		1.7040824					Non-Inferiority	1-sided Confidence interval

Primary

Number of Participants With Death or First Thromboembolic Event (DTE)

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall)

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Primary

Number of Participants With Primary Bleeding Event (PBE)

PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Secondary

Number of Participants With Net-clinical Benefit

The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Secondary

Number of Participants With Cardiovascular Death or Thromboembolic Event

Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Secondary

Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds

Composite of TIMI major and minor bleedings

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Secondary

Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds

ISTH major bleeds

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Secondary

Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds

Composite of BARC 2,3 or 5 bleedings

Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).

Posted

Count of Participants

Participants

Through study completion, on average 16 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939)	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
OG001	Antiplatelet	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban Arm	Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.	70	801	296	801	359	801
EG001	Antiplatelet Arm	Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.	43	807	282	807	302	807

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0010 events0 affected807 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0010 events0 affected807 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Angina pectoris	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Arrhythmia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG00019 events17 affected801 at risk EG00127 events25 affected807 at risk
Atrial flutter	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Atrioventricular block	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG00012 events12 affected801 at risk EG00115 events15 affected807 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Bradycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Bundle branch block left	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0016 events6 affected807 at risk
Cardiac arrest	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0011 events1 affected807 at risk
Cardiac failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG00019 events16 affected801 at risk EG00122 events16 affected807 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG00110 events5 affected807 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0008 events8 affected801 at risk EG0014 events3 affected807 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Conduction disorder	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Coronary artery disease	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0008 events5 affected801 at risk EG0015 events3 affected807 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Extrasystoles	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Left ventricular failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Myocarditis	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Palpitations	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Right ventricular failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Sinus arrest	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Torsade de pointes	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Trifascicular block	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Coronary artery dissection	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0014 events4 affected807 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Neuroacanthocytosis	Congenital, familial and genetic disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Primary adrenal insufficiency	Endocrine disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Blindness	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cataract	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0014 events2 affected807 at risk
Keratitis	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Macular degeneration	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Retinal detachment	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Neovascular age-related macular degeneration	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Macular detachment	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Enteritis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Gastritis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ileus	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0011 events1 affected807 at risk
Subileus	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Asthenia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Chest pain	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Death	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0015 events5 affected807 at risk
Fatigue	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Gait disturbance	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Impaired healing	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Malaise	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Oedema peripheral	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pain	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Pyrexia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Strangulated hernia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Sudden death	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Sudden cardiac death	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
General physical health deterioration	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cardiac death	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Exercise tolerance decreased	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0010 events0 affected807 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Inflammation	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Non-cardiac chest pain	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events3 affected801 at risk EG0011 events1 affected807 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Jaundice	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Sarcoidosis	Immune system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Haemophagocytic lymphohistiocytosis	Immune system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Bacteraemia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Bronchitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0010 events0 affected807 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cellulitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0014 events4 affected807 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Diverticulitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Endocarditis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0008 events8 affected801 at risk EG0017 events7 affected807 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Endocarditis enterococcal	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Erysipelas	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events2 affected807 at risk
Gangrene	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0014 events4 affected807 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Herpes zoster	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Infected skin ulcer	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Influenza	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Liver abscess	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Orchitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Parotitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Peritonitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pneumonia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG00028 events23 affected801 at risk EG00123 events22 affected807 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Postoperative wound infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events1 affected807 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Sepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0013 events3 affected807 at risk
Sialoadenitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Tooth abscess	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Tracheobronchitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Typhoid fever	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0013 events3 affected807 at risk
Viral infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Wound infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Urosepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0011 events1 affected807 at risk
Groin infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pulmonary sepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Arthritis bacterial	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0005 events2 affected801 at risk EG0011 events1 affected807 at risk
Biliary sepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Abdominal sepsis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Wound abscess	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Renal cyst infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Intervertebral discitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Diabetic foot infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Lung infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Streptococcal infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Peritonitis bacterial	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cardiac valve abscess	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Dermo-hypodermitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0010 events0 affected807 at risk
Post procedural infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Septic encephalopathy	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Streptococcal endocarditis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Medical device site joint infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Accident	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG00012 events12 affected801 at risk EG0015 events5 affected807 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Pancreatic injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0011 events1 affected807 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events1 affected807 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Coronary bypass stenosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Arterial bypass stenosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Post procedural hypoparathyroidism	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Product administration error	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Haemoglobin decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Heart rate irregular	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Weight decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Ejection fraction decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Troponin increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Inflammatory marker increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Influenza A virus test positive	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Transvalvular pressure gradient increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0011 events1 affected807 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0011 events1 affected807 at risk
Gout	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0013 events2 affected807 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0014 events4 affected807 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events3 affected801 at risk EG00110 events10 affected807 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0014 events3 affected807 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Ear neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Axonal neuropathy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events1 affected807 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Dementia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Dizziness	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0009 events9 affected801 at risk EG0014 events4 affected807 at risk
Encephalopathy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Epilepsy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0012 events1 affected807 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events1 affected801 at risk EG0010 events0 affected807 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Hypotonia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Loss of consciousness	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Mental impairment	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Migraine	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Myasthenia gravis	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Myelopathy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Nerve compression	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Parkinsonism	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Presyncope	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Sciatica	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events4 affected801 at risk EG0012 events2 affected807 at risk
Seizure	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Syncope	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG00020 events19 affected801 at risk EG00125 events23 affected807 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Balance disorder	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Vascular dementia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events1 affected807 at risk
Ballismus	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Parkinson's disease	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Brain injury	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Confusional state	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0011 events1 affected807 at risk
Delirium	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Depression	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0011 events1 affected807 at risk
Hallucination	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Panic disorder	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Suicide attempt	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Mental status changes	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Renal failure	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Urinary retention	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events1 affected807 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Renal impairment	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG00117 events17 affected807 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Rectocele	Reproductive system and breast disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0009 events7 affected801 at risk EG0019 events7 affected807 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0016 events6 affected807 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events5 affected801 at risk EG0011 events1 affected807 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Lichen sclerosus	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0014 events3 affected807 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cochlea implant	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Incisional hernia repair	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Skin cyst excision	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Toe amputation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Shoulder arthroplasty	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Hip surgery	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Peripheral artery angioplasty	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Dental operation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Ear operation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Eyelid operation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Hernia repair	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Cardiac pacemaker adjustment	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Transcatheter arterial chemoembolisation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Aortic dissection	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Aortic stenosis	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Circulatory collapse	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0015 events5 affected807 at risk
Hypertensive crisis	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0016 events5 affected807 at risk
Hypotension	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0011 events1 affected807 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Intermittent claudication	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Varicose vein	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0018 events8 affected807 at risk
Undersensing	Product Issues	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0011 events1 affected807 at risk
Device battery issue	Product Issues	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0010 events0 affected807 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG0013 events3 affected807 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0010 events0 affected807 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Angina pectoris	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0015 events4 affected807 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG00044 events43 affected801 at risk EG00145 events44 affected807 at risk
Atrial flutter	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0015 events5 affected807 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0018 events8 affected807 at risk
Bradycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Bundle branch block left	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events6 affected801 at risk EG0017 events7 affected807 at risk
Cardiac failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG00015 events14 affected801 at risk EG00111 events11 affected807 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0013 events3 affected807 at risk
Left ventricular failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Palpitations	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0013 events3 affected807 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0012 events2 affected807 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG00017 events17 affected801 at risk EG0018 events8 affected807 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Hypothyroidism	Endocrine disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0017 events7 affected807 at risk
Cataract	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0016 events5 affected807 at risk
Lacrimation increased	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Vision blurred	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Visual impairment	Eye disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events6 affected801 at risk EG0010 events0 affected807 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0008 events8 affected801 at risk EG0016 events6 affected807 at risk
Constipation	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0015 events5 affected807 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG00012 events11 affected801 at risk EG00111 events9 affected807 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Gastritis	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Nausea	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG0014 events4 affected807 at risk
Toothache	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0014 events4 affected807 at risk
Asthenia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Chest pain	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG00112 events12 affected807 at risk
Fatigue	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG00015 events13 affected801 at risk EG0017 events7 affected807 at risk
Gait disturbance	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Oedema	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0013 events3 affected807 at risk
Oedema peripheral	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG00016 events16 affected801 at risk EG00121 events20 affected807 at risk
Pyrexia	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0014 events2 affected807 at risk
Peripheral swelling	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
General physical health deterioration	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Drug intolerance	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Non-cardiac chest pain	General disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0015 events5 affected807 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Bronchitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG00010 events9 affected801 at risk EG00112 events12 affected807 at risk
Cellulitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0014 events4 affected807 at risk
Conjunctivitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Cystitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0013 events3 affected807 at risk
Erysipelas	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Fungal infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0010 events0 affected807 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Gingivitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Herpes zoster	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Influenza	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0013 events3 affected807 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Nasopharyngitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0015 events5 affected807 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Pneumonia	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0006 events5 affected801 at risk EG00110 events10 affected807 at risk
Pulpitis dental	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0010 events0 affected807 at risk
Sinusitis	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0010 events0 affected807 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG00033 events30 affected801 at risk EG00121 events19 affected807 at risk
Respiratory tract infection	Infections and infestations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG00018 events18 affected801 at risk EG00116 events16 affected807 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0014 events4 affected807 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG00011 events11 affected801 at risk EG00111 events8 affected807 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0010 events0 affected807 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Blood creatinine increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0014 events4 affected807 at risk
Blood glucose increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Blood pressure increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0014 events4 affected807 at risk
C-reactive protein increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
Electrocardiogram QRS complex prolonged	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Haemoglobin decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0013 events3 affected807 at risk
International normalised ratio abnormal	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Intraocular pressure increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Weight increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Ejection fraction decreased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0015 events5 affected807 at risk
Transvalvular pressure gradient increased	Investigations	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0015 events5 affected807 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0012 events2 affected807 at risk
Gout	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0008 events7 affected801 at risk EG0011 events1 affected807 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0013 events2 affected807 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0015 events5 affected807 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events9 affected801 at risk EG0015 events5 affected807 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG00012 events11 affected801 at risk EG0016 events5 affected807 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0010 events0 affected807 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0013 events3 affected807 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0014 events4 affected807 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0013 events3 affected807 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0011 events1 affected807 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0007 events7 affected801 at risk EG0019 events9 affected807 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Amnesia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events2 affected801 at risk EG0011 events1 affected807 at risk
Dementia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Dizziness	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG00032 events32 affected801 at risk EG00116 events16 affected807 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG0014 events4 affected807 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0013 events3 affected807 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Presyncope	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0005 events5 affected801 at risk EG0013 events3 affected807 at risk
Sciatica	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Seizure	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Syncope	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG00116 events15 affected807 at risk
Cognitive disorder	Nervous system disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Anxiety	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Confusional state	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Depression	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Insomnia	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Mental status changes	Psychiatric disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events2 affected807 at risk
Nocturia	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Renal failure	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0012 events1 affected807 at risk
Urinary retention	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0013 events3 affected807 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events6 affected801 at risk EG0018 events8 affected807 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0009 events8 affected801 at risk EG0017 events6 affected807 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0016 events6 affected807 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG00017 events17 affected801 at risk EG0016 events6 affected807 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0014 events2 affected807 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0013 events3 affected807 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events5 affected801 at risk EG0015 events5 affected807 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0013 events3 affected807 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0010 events0 affected807 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0011 events1 affected807 at risk
Tooth extraction	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG00010 events10 affected801 at risk EG0010 events0 affected807 at risk
Cataract operation	Surgical and medical procedures	MedDRA (21.1)	Non-systematic Assessment	EG0009 events6 affected801 at risk EG0011 events1 affected807 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG0012 events2 affected807 at risk
Haematoma	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0001 events1 affected801 at risk EG0012 events2 affected807 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG00026 events26 affected801 at risk EG00128 events28 affected807 at risk
Hypertensive crisis	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0012 events2 affected807 at risk
Hypotension	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0003 events3 affected801 at risk EG00111 events10 affected807 at risk
Intermittent claudication	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Lymphoedema	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0004 events4 affected801 at risk EG0010 events0 affected807 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0010 events0 affected807 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0002 events2 affected801 at risk EG0011 events1 affected807 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0006 events6 affected801 at risk EG0012 events2 affected807 at risk
Peripheral venous disease	Vascular disorders	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk
Device dislocation	Product Issues	MedDRA (21.1)	Non-systematic Assessment	EG0000 events0 affected801 at risk EG0012 events2 affected807 at risk

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

ID	Term
D000069552	Rivaroxaban
D001241	Aspirin
D000077144	Clopidogrel
C008208	acarboxyprothrombin