Evaluation of Dual Therapy With Dabigatran vs. Triple The... | NCT02164864

ID	Type	Description	Link
2013-003201-26	EudraCT Number

Label	Type	Description	Intervention Names
Dabigatran Etexilate 110mg	Experimental	Patient to receive Dabigatran Etexilate 110mg twice a day (BID)	Drug: Dabigatran Etexilate 110mg Drug: Clopidogrel or Ticagrelor
Dabigatran Etexilate 150mg	Experimental	Patient to receive Dabigatran Etexilate 150mg twice a day (BID)	Drug: Dabigatran Etexilate 150mg Drug: Clopidogrel or Ticagrelor
Warfarin	Active Comparator	Warfarin doses to maintain INR	Drug: Warfarin 3mg Drug: Aspirin Drug: Clopidogrel or Ticagrelor Drug: Warfarin 5mg Drug: Warfarin 1mg

Name	Type	Description	Arm Group Labels	Other Names
Dabigatran Etexilate 110mg	Drug	Active treatment	Dabigatran Etexilate 110mg

Measure	Description	Time Frame
Time to First Adjudicated ISTH MBE or CRNMBE	Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.	up to 30 months

Measure	Description	Time Frame
Time to Adjudicated Undetermined Cause of Death	Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology P.C.		Birmingham	Alabama	35211	United States
Verde Valley Medical Center

PubMed Identifier	Type	Citation	Retractions
32562206	Derived	Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.
32389658

ID	Title	Description
FG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
FG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 21, 2016	Jun 4, 2018

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

Time to First Adjudicated ISTH MBE or CRNMBE

Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.

Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.

Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.

Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003	Warfarin (Excluding Elder Patients Outside USA)	Patients were orally administered warfarin once daily. The warfarin dose was titrated as needed to maintain the target INR of 2.0 to 3.0 ; 2.0 to 2.5 if feasible. Elderly patients who were outside the USA were excluded.

Units	Counts
Participants	OG000981 OG001763 OG002981 OG003

Title

Denominators

Categories

Title	Measurements
	OG000151 OG001154 OG002264 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.	Regression, Cox	The Cox proportional hazard model is stratified by age, non-elderly vs elderly [<70 or >=70 in Japan and <80 or >=80 years old elsewhere].	<0.0001	P values for noninferiority were calculated at a one-sided alpha level of 0.025	Hazard Ratio (HR)	0.52			2-Sided	95	0.42	0.63			Hazard Ratio (HR) and Wald confidence intervals are derived from a Cox proportional-hazard model

Secondary

Time to Adjudicated Undetermined Cause of Death

Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.

This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was "patient died") or when there was insufficient supporting information or detail to assign the cause of death.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Secondary

Time to Adjudicated Non-CV

Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.

Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin

Secondary

Time to Adjudicated CV

Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.

CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Secondary

Time to Adjudicated All Cause Death

Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003

Secondary

Time to First Adjudicated MI

Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003	Warfarin (Excluding Elder Patients Outside USA)

Secondary

Time to First Adjudicated Stroke

Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.

Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Secondary

Time to First Adjudicated SE

Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.

SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Secondary

Time to First Adjudicated ST

Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003	Warfarin (Excluding Elder Patients Outside USA)

Secondary

Time to Composite Endpoint of Death + MI + Stroke

Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003	Warfarin (Excluding Elder Patients Outside USA)

Secondary

Time to Composite Endpoint of Death or First Thrombotic Event

Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Secondary

Time to First Adjudicated Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
OG003

Secondary

Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG

Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.

Full Analysis set (FAS) following the intention-to-treat principle.

Posted

Count of Participants

Participants

up to 30 months

ID	Title	Description
OG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
OG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
OG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0017 affected758 at risk EG0027 affected948 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0024 affected948 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00020 affected972 at risk EG00114 affected758 at risk EG00215 affected948 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00020 affected972 at risk EG00118 affected758 at risk EG00218 affected948 at risk
Angina unstable	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00026 affected972 at risk EG00115 affected758 at risk EG00213 affected948 at risk
Aortic valve disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00044 affected972 at risk EG00136 affected758 at risk EG00234 affected948 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00018 affected972 at risk EG0018 affected758 at risk EG0026 affected948 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0015 affected758 at risk EG0026 affected948 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0011 affected758 at risk EG0025 affected948 at risk
Cardiac asthma	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00048 affected972 at risk EG00130 affected758 at risk EG00246 affected948 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected972 at risk EG0015 affected758 at risk EG0024 affected948 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected972 at risk EG0011 affected758 at risk EG0023 affected948 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00014 affected972 at risk EG00113 affected758 at risk EG00219 affected948 at risk
Cardiac flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0016 affected758 at risk EG0027 affected948 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG00112 affected758 at risk EG0023 affected948 at risk
Heart valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Microvascular coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG00017 affected972 at risk EG0018 affected758 at risk EG0028 affected948 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0025 affected948 at risk
Palpitations	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Pericarditis	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Right ventricular failure	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0023 affected948 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Sinus arrest	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0012 affected758 at risk EG0023 affected948 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0015 affected758 at risk EG0021 affected948 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Trifascicular block	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ventricle rupture	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected972 at risk EG0015 affected758 at risk EG0023 affected948 at risk
Generalised resistance to thyroid hormone	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Venous angioma of brain	Congenital, familial and genetic disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Deafness	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0013 affected758 at risk EG0020 affected948 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Thyroid mass	Endocrine disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Blindness transient	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Cataract	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0013 affected758 at risk EG0023 affected948 at risk
Eye haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Glaucoma	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0012 affected758 at risk EG0022 affected948 at risk
Neovascular age-related macular degeneration	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Retinal detachment	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0013 affected758 at risk EG0022 affected948 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0022 affected948 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Dental cyst	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected972 at risk EG0015 affected758 at risk EG00213 affected948 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Gastrointestinal tract irritation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0013 affected758 at risk EG0022 affected948 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0011 affected758 at risk EG0024 affected948 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0013 affected758 at risk EG0024 affected948 at risk
Rectal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Stomach mass	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Adverse drug reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Asthenia	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0025 affected948 at risk
Cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Chest discomfort	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG00014 affected972 at risk EG00115 affected758 at risk EG00215 affected948 at risk
Death	General disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected972 at risk EG0016 affected758 at risk EG0025 affected948 at risk
Device related thrombosis	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Drug effect increased	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Gait disturbance	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
General physical health deterioration	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Impaired healing	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Implant site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Injection site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Localised oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Malaise	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Medical device site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0013 affected758 at risk EG0021 affected948 at risk
Oedema	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Oedema peripheral	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Puncture site haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Pyrexia	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Sudden cardiac death	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Sudden death	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0027 affected948 at risk
Ulcer	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ulcer haemorrhage	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Vascular stent occlusion	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Vascular stent restenosis	General disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0014 affected758 at risk EG0023 affected948 at risk
Vascular stent stenosis	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Vascular stent thrombosis	General disorders	MedDRA 20.0	Systematic Assessment	EG00025 affected972 at risk EG00110 affected758 at risk EG00217 affected948 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Biliary cirrhosis primary	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0012 affected758 at risk EG0024 affected948 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0011 affected758 at risk EG0023 affected948 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Anal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Appendicitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Bone abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bronchiolitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0022 affected948 at risk
Candida infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Cellulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0016 affected758 at risk EG0023 affected948 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Dengue fever	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Device related infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Empyema	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Epididymitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Erysipelas	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Gangrene	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Gastritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Helicobacter infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Hepatitis C	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Infected cyst	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0013 affected758 at risk EG0023 affected948 at risk
Labyrinthitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Liver abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Lung infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Orchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Pharyngitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG00020 affected972 at risk EG00115 affected758 at risk EG00219 affected948 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Pseudomonas infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Renal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Rhinovirus infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Scrotal abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0015 affected758 at risk EG0024 affected948 at risk
Septic shock	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0013 affected758 at risk EG0022 affected948 at risk
Skin bacterial infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Soft tissue infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Systemic infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0013 affected758 at risk EG0024 affected948 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Urosepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Viral infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Chemical burn	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0012 affected758 at risk EG0025 affected948 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Iatrogenic injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Near drowning	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Postoperative renal failure	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0023 affected948 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Blood creatinine increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Blood pressure abnormal	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Blood urine	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Blood urine present	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
C-reactive protein increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Haematocrit decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Haemoglobin decreased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0014 affected758 at risk EG0022 affected948 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
International normalised ratio increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0029 affected948 at risk
Liver function test increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Occult blood positive	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Troponin increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0024 affected948 at risk
Hyperhomocysteinaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0013 affected758 at risk EG0022 affected948 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected972 at risk EG0014 affected758 at risk EG0022 affected948 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Plica syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0011 affected758 at risk EG0024 affected948 at risk
Benign gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Carcinoma in situ of penis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Cerebral haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lung carcinoma cell type unspecified stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Non-small cell lung cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0012 affected758 at risk EG0023 affected948 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Rectal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Tumour ulceration	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Urinary bladder adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Brain injury	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Brain oedema	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Brain stem infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0014 affected758 at risk EG0024 affected948 at risk
Dementia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Diplegia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Disturbance in attention	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Dizziness postural	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Drop attacks	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Encephalomalacia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Epilepsy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Facial paresis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0013 affected758 at risk EG0020 affected948 at risk
Hemiplegia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0014 affected758 at risk EG0021 affected948 at risk
Lacunar infarction	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lateral medullary syndrome	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Mental impairment	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Migraine	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Movement disorder	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Quadriparesis	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Sciatica	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Somnolence	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Spinal claudication	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0009 affected972 at risk EG00110 affected758 at risk EG0027 affected948 at risk
Tension headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Device malfunction	Product Issues	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Anxiety	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Confusional state	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Mental status changes	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Paranoia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Transient psychosis	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG00015 affected972 at risk EG00114 affected758 at risk EG0026 affected948 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0014 affected758 at risk EG0027 affected948 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0013 affected758 at risk EG0021 affected948 at risk
Renal cyst	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0013 affected758 at risk EG0022 affected948 at risk
Renal impairment	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Renal infarct	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Renal mass	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0013 affected758 at risk EG0023 affected948 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0016 affected758 at risk EG0026 affected948 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG00011 affected972 at risk EG00110 affected758 at risk EG00217 affected948 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0013 affected758 at risk EG0029 affected948 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected972 at risk EG0012 affected758 at risk EG0025 affected948 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected972 at risk EG0010 affected758 at risk EG0023 affected948 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0007 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0014 affected758 at risk EG0021 affected948 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0022 affected948 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Angiodysplasia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0021 affected948 at risk
Aortic dissection	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Aortic dissection rupture	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Aortic necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Aortic stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Aortic thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Aortitis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Circulatory collapse	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0021 affected948 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Extremity necrosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Femoral artery dissection	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Haematoma	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0011 affected758 at risk EG0027 affected948 at risk
Haemorrhage	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0012 affected758 at risk EG0026 affected948 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0006 affected972 at risk EG0015 affected758 at risk EG0021 affected948 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0008 affected972 at risk EG0013 affected758 at risk EG00211 affected948 at risk
Hypertensive emergency	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0012 affected758 at risk EG0026 affected948 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Intermittent claudication	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0011 affected758 at risk EG0020 affected948 at risk
Ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0020 affected948 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0005 affected972 at risk EG0011 affected758 at risk EG0025 affected948 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0022 affected948 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Peripheral embolism	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0012 affected758 at risk EG0020 affected948 at risk
Shock	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Temporal arteritis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk
Thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected972 at risk EG0010 affected758 at risk EG0021 affected948 at risk

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

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D015110	4-Hydroxycoumarins
D003374	Coumarins
D001578	Benzopyrans
D011714	Pyrans
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D012263	Ribonucleosides

ID	Title	Description
BG000	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.
BG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.
BG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible
BG003	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	Dabigatran Etexilate 110mg	Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months.	38	972	415	972	128	972
EG001	Dabigatran Etexilate 150mg	Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months.	24	758	300	758	126	758
EG002	Warfarin	Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible	41	948	396	948	229	948

ID	Term
D000069604	Dabigatran
D014859	Warfarin
D001241	Aspirin
D000077144	Clopidogrel
D000077486	Ticagrelor