Edoxaban Compared to Standard Care After Heart Valve Repl... | NCT02943785

ID	Type	Description	Link
2016-003930-26	EudraCT Number

Name	Class
Chiltern International Inc.	INDUSTRY

Label	Type	Description	Intervention Names
Edoxaban-based Regimen	Experimental	Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing must follow the locally approved label.	Drug: Edoxaban-based Regimen
VKA-based Regimen	Active Comparator	VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.	Drug: VKA-based Regimen

Name	Type	Description	Arm Group Labels	Other Names
Edoxaban-based Regimen	Drug	15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)	Edoxaban-based Regimen

Measure	Description	Time Frame
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA	The composite endpoint net adverse clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Haemostasis (ISTH].	Baseline through study completion, up to 36 months post-dose
Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA	ISTH Bleeding Criteria for Major Bleeding are defined as clinically overt bleeding that is associated with: a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or a transfusion of 2 or more units of whole blood or packed red blood cells, or symptomatic bleeding into a critical site or organ such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or a fatal outcome.	Baseline through study completion, up to 36 months post-dose

Measure	Description	Time Frame
Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA	The composite endpoint of net adverse event clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria. Bleeding by TIMI criteria was defined as the following: (1) Major, any intracranial hemorrhage or any clinically overt bleeding, (including bleeding evident in imaging studies) associated with a fall of hemoglobin (Hb) of ≥ 5g/dL or fatal bleeding and (2) Minor, any clinically overt bleeding associated with a fall in Hb ≥ 3g/dL but < 5 g/dL.

Name	Affiliation	Role
Global Clinical Leader	Daiichi Sankyo	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
University of Arizona Sarver Heart Center

PubMed Identifier	Type	Citation	Retractions
41263742	Derived	Van Mieghem NM, Chen C, Hengstenberg C, Van Zyl J, Kimura T, Lang I, Mehran R, Nicolas J, Unverdorben M, Zamorano JL, Dangas GD. Edoxaban Dose Adjustment and Age-Associated Outcomes in Patients With Atrial Fibrillation Post-Transcatheter Aortic Valve Replacement. JACC Adv. 2025 Dec;4(12 Pt 1):102329. doi: 10.1016/j.jacadv.2025.102329. Epub 2025 Nov 19.
40371611

ID	Title	Description
FG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
FG001	Vitamin K Antagonist (VKA)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 29, 2019

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 Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA

The composite endpoint net adverse clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Haemostasis (ISTH].

Net adverse clinical events were assessed in the Intent-to-Treat (ITT) Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts
Participants	OG000713 OG001713

Title

Denominators

Categories

Title	Measurements
	OG000170 OG001157

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		Regression, Cox		0.0141		Cox Proportional Hazard	1.05			2-Sided	95	0.85	1.31					Non-Inferiority	The two-sided p-value (Noninferiority) was based on the noninferiority margin of 1.38.

Primary

Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA

ISTH Bleeding Criteria for Major Bleeding are defined as clinically overt bleeding that is associated with: a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or a transfusion of 2 or more units of whole blood or packed red blood cells, or symptomatic bleeding into a critical site or organ such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or a fatal outcome.

Bleeding events were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Secondary

Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA

The composite endpoint of net adverse event clinical events (NACE) included all-cause death, myocardial infarction (MI), ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding based on Thrombolysis in Myocardial Infarction (TIMI) criteria. Bleeding by TIMI criteria was defined as the following: (1) Major, any intracranial hemorrhage or any clinically overt bleeding, (including bleeding evident in imaging studies) associated with a fall of hemoglobin (Hb) of ≥ 5g/dL or fatal bleeding and (2) Minor, any clinically overt bleeding associated with a fall in Hb ≥ 3g/dL but < 5 g/dL.

Net adverse clinical events were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Secondary

Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA

The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Bleeding Academic Research Consortium (BARC) Type 3 or 5 criteria. Major bleeding by BARC criteria was defined as Type 3: clinical, laboratory, and/or imaging evidence of bleeding with provider responses; Type 3a: any transfusion with overt bleeding; overt bleeding plus Hb drop of 3 to < 5 g/dL; Type 3b: overt bleeding plus Hb drop ≥ 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring intravenous vasoactive drugs; Type 3c: intracranial hemorrhage; subcategories confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision; Type 5: fatal bleeding; Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious; Type 5b: definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

Net adverse clinical events were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001

Secondary

Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA

The composite endpoint of net adverse event clinical events (NACE) included all-cause death, MI, ischemic stroke, SEE, valve thrombosis, and major bleeding based on Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO). GUSTO criteria was defined as the following: severe or life threatening: intracerebral hemorrhage or resulting in substantial hemodynamic compromise requiring treatment and moderate: requiring blood transfusion but not resulting in hemodynamic compromise.

Net adverse clinical events were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Secondary

Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Major adverse cardiac events (MACE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, or repeat coronary revascularization of the target lesion.

MACE were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Major adverse cardiac and cerebrovascular events (MACCE) is defined as the composite of all-cause death (excluding adjudicated non-cardiac death), MI, stroke (ischemic, hemorrhagic, or undetermined), or repeat coronary revascularization of the target lesion

MACE were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts

Secondary

Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)

A composite of clinical adverse events included cardiovascular death, MI ischemic stroke, SEE, valve thrombosis, and major bleeding as defined by ISTH criteria.

A composite of adverse events was assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Stroke events are categorized as any stroke, fatal stroke, and non-fatal stroke.

Stroke events were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts
Participants

Secondary

Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Systemic thromboembolism [non-central nervous system] is defined as abrupt vascular insufficiency of an extremity or organ associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (e.g., trauma, atherosclerosis, instrumentation).

Systemic embolic events (SEE) were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units

Secondary

Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Peri-procedural MI was defined as new ischemic symptoms or signs and elevated cardiac biomarkers within 72 hours after index procedure, consisting of at least one sample post-procedure with a peak value exceeding 15x as the upper reference limit (URL) for troponin or 5x for CK-MB. Spontaneous MI is defined as any one of the following: Detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile URL, together with the evidence of myocardial ischemia with at least one of the following: Symptoms of ischemia; ECG changes indicative of new ischemia; New pathological Q-waves in at least two contiguous leads; Imaging evidence of a new loss of viable myocardium or new wall motion abnormality; Sudden, unexpected cardiac death, involving cardiac arrest, often with symptoms suggestive of myocardial ischemia, and accompanied by new ST elevation or new left bundle branch block, and/or evidence of fresh thrombus; Pathological findings of an acute MI.

Myocardial infarctions were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001

Secondary

Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data)

Valve thrombosis was defined as any thrombus attached to or near an implanted valve that occludes part of the blood flow path, interferes with valve function, or is sufficiently large to warrant treatment.

Valve thrombosis were assessed in the ITT Analysis Set.

Posted

Count of Participants

Participants

Baseline through study completion, up to 36 months post-dose

ID	Title	Description
OG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
OG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00039 affected693 at risk EG00137 affected684 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00021 affected693 at risk EG00117 affected684 at risk
Endocarditis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG00014 affected693 at risk EG0017 affected684 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG00113 affected684 at risk
Sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0017 affected684 at risk
Bronchitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0015 affected684 at risk
COVID-19	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0016 affected684 at risk
Septic shock	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0013 affected684 at risk
Urosepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0012 affected684 at risk
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0014 affected684 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0013 affected684 at risk
Bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0013 affected684 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0014 affected684 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0011 affected684 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0011 affected684 at risk
Appendicitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0013 affected684 at risk
Cystitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Erysipelas	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Intervertebral discitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Streptococcal endocarditis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Enterococcal infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Epididymitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Escherichia sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Gangrene	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Herpes zoster	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Klebsiella infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Abscess soft tissue	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Alveolar osteitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Anal abscess	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Aspergilloma	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Bacterial sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Citrobacter sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Cystitis klebsiella	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Device-related sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Diverticulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Endocarditis enterococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Escherichia infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Fracture infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Fungal tracheitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Gastric infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Groin infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Herpes zoster oticus	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Infected lymphocele	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Infective aneurysm	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Medical device site infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Mycotic corneal ulcer	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Nosocomial infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Peritonitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Postoperative wound infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Rhinovirus infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Salmonellosis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Viral infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Wound infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Metastases to pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Refractory cytopenia with unilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG00031 affected693 at risk EG00111 affected684 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0011 affected684 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0013 affected684 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0016 affected684 at risk
Anaemia folate deficiency	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Normochromic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Anaphylatic shock	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0013 affected684 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0013 affected684 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Fructose intolerance	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Gout	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Confusional state	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0011 affected684 at risk
Anxiety	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Drug dependence	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Mental status changes	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Stress	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Syncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG00013 affected693 at risk EG00112 affected684 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0009 affected693 at risk EG00110 affected684 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG0018 affected684 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0015 affected684 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0011 affected684 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0014 affected684 at risk
Embolic stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0011 affected684 at risk
Cognitive disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0011 affected684 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0013 affected684 at risk
Haemorrhage stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0013 affected684 at risk
Chorea	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Epilepsy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Presyncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Dementia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Lacunar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Amnesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Choreoathetosis	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Dysaesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Dysarthria	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Headache	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Lacunar stroke	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Paraesthesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Parkinson's disease	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Partial seizures	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Sciatica	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Status epileticus	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cataract	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Retinal artery occlusion	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Amaurosis fugax	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Choroidal detachment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Retinal haemorrhage	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Vitreous detachment	Eye disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Vestibular paroxysmia	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00057 affected693 at risk EG00164 affected684 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00017 affected693 at risk EG00118 affected684 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG00023 affected693 at risk EG00112 affected684 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0008 affected693 at risk EG00111 affected684 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0009 affected693 at risk EG0016 affected684 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0018 affected684 at risk
Bradycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0013 affected684 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0017 affected684 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0011 affected684 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0014 affected684 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Pericardial effusion	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0011 affected684 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0013 affected684 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0011 affected684 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0014 affected684 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Bundle branch block left	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Arrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Cardiac asthma	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Left ventricular failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Sinus arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Angina unstable	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Aortic valve disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Bifascicular block	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Conduction disorder	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Cor pulmonale	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Mitral valve disease	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pericarditis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Prosthetic cardiac valve thrombosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Right ventricular failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG0015 affected684 at risk
Haematoma	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0019 affected684 at risk
Hypertensive crisis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0008 affected693 at risk EG0011 affected684 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0011 affected684 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Aortic dissection	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Circulatory collapse	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Phlebitis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Aortic occlusion	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Aortic perforation	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Aortic thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Blue toe syndrome	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Extremity necrosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Femoral artery embolism	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Haemorrhage	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Peripheral embolism	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Peripheral venous disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Varicose vein	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG00011 affected693 at risk EG0018 affected684 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG0018 affected684 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0017 affected684 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG0013 affected684 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0013 affected684 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0013 affected684 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pharyngeal haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG00016 affected693 at risk EG0017 affected684 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0008 affected693 at risk EG0014 affected684 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0007 affected693 at risk EG0011 affected684 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0013 affected684 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0016 affected684 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Melaena	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Diverticulum intestinal hemorrhagic	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Enterocele	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pancreatic failure	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Subileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Ulcerative duodenitis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0013 affected684 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0013 affected684 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0013 affected684 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0013 affected684 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Chest wall haematoma	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Osteonecrosis of jaw	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Soft tissue disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG00018 affected693 at risk EG00117 affected684 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG00011 affected693 at risk EG0013 affected684 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0015 affected684 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0010 affected684 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Renal impairment	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Renal haematoma	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Renal infarct	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Death	General disorders	MedDRA 19.1	Systematic Assessment	EG0008 affected693 at risk EG0013 affected684 at risk
General physical health deterioration	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0016 affected684 at risk
Asthenia	General disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0014 affected684 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0012 affected684 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Sudden death	General disorders	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0012 affected684 at risk
Impaired healing	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0012 affected684 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Malaise	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Chest discomfort	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Fatigue	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Injection site haematoma	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Peripheral swelling	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Stent-graft endoleak	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Sudden cardiac death	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
International normalised ratio increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0015 affected684 at risk
Haemoglobin decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Troponin increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Blood lactic acid increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Coronavirus test positive	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Ejection fraction decreased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
General physical condition normal	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Heart rate irregular	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Hepatic enzyme increased	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Inflammatory marker increased	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Myocardial necrosis marker increased	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Weight increased	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0006 affected693 at risk EG0018 affected684 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0009 affected693 at risk EG0014 affected684 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0005 affected693 at risk EG0016 affected684 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0015 affected684 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0004 affected693 at risk EG0013 affected684 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0013 affected684 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0014 affected684 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0014 affected684 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0013 affected684 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0014 affected684 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0012 affected684 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0013 affected684 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0011 affected684 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0013 affected684 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0002 affected693 at risk EG0010 affected684 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0012 affected684 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Vascular access site pseduoaneurysm	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Colon injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Heat illness	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Open globe injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Vascular access site haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0010 affected684 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk
Device leakage	Product Issues	MedDRA 19.1	Systematic Assessment	EG0003 affected693 at risk EG0010 affected684 at risk
Device malfunction	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 affected693 at risk EG0011 affected684 at risk
Device power source issue	Product Issues	MedDRA 19.1	Systematic Assessment	EG0000 affected693 at risk EG0011 affected684 at risk

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

ID	Title	Description
BG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.
BG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Edoxaban	Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label.	83	693	388	693	522	693
EG001	Vitamin K Antagonist (VKA)	Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target.	78	684	372	684	429	684