A Study of Rivaroxaban (JNJ-39039039) on the Venous Throm... | NCT02111564

NCT02111564

ID	Type	Description	Link
2014-000305-13	EudraCT Number
RIVAROXDVT3002	Other Identifier	Janssen Research & Development, LLC

Status Module

Name	Class
Bayer	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban	Experimental	Each patient will receive either 10 mg or 7.5 mg rivaroxaban tablet once daily orally (by mouth) for 45 days. The dosing will depend on a creatinine clearance at screening.	Drug: Rivaroxaban, 10 mg Drug: Rivaroxaban, 7.5 mg
Placebo	Placebo Comparator	Each patient will receive matching placebo tablet once daily orally (by mouth) for 45 days.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban, 10 mg	Drug	Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)	Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.	Up to Day 45
Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC	A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.	From randomization to 2 days after the last dose (Day 45)

Secondary Outcomes

Measure	Description	Time Frame
Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC	Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Eligibility Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26842902	Background	Raskob GE, Spyropoulos AC, Zrubek J, Ageno W, Albers G, Elliott CG, Halperin J, Haskell L, Hiatt WR, Maynard GA, Peters G, Spiro T, Steg PG, Suh EY, Weitz JI. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016 Jun 2;115(6):1240-8. doi: 10.1160/TH15-09-0756. Epub 2016 Feb 4.
36205248

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 31, 2017	Nov 5, 2019

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
BG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00069.7± 10.06 BG00169.7± 10.22 BG00269.7± 10.14

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002877 BG0012858 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000499 BG001482 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0009 BG0015 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

ARGENTINA

Title	Measurements
	BG000120 BG001122 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)

Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Units	Counts
Participants	OG0006007 OG0016012

Title

Denominators

Categories

Title	Measurements
	OG0000.84 OG0011.11

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cox proportional hazards model		0.136		Hazard Ratio (HR)	0.76			2-Sided	95	0.52	1.09					Superiority

Primary

Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC

A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.

The Safety analysis set included all enrolled participants in the ITT analysis set who received at least 1 dose of study drug.

Posted

Number

Events per 100 participants in 45 days

From randomization to 2 days after the last dose (Day 45)

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo

Secondary

Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC

Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Units	Counts

Secondary

Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Secondary

Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Units

Secondary

Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Secondary

Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Posted

Number

Events per 100 participants in 45 days

Up to Day 45

ID	Title	Description
OG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.
OG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban 10 mg or 7.5 mg	Participants with a creatinine clearance (CrCl) greater than or equal to (>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	115	6,007	475	6,007	250	6,007
EG001	Placebo	Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.	126	6,012	493	6,012	280	6,012

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0010 affected6,012 at risk
Autoimmune Haemolytic Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Acute Left Ventricular Failure	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Angina Pectoris	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0011 affected6,012 at risk
Aortic Valve Incompetence	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00013 affected6,007 at risk EG00110 affected6,012 at risk
Atrial Flutter	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0016 affected6,012 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0011 affected6,012 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Bradycardia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Cardiac Arrest	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0005 affected6,007 at risk EG0015 affected6,012 at risk
Cardiac Asthma	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Cardiac Failure	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00051 affected6,007 at risk EG00162 affected6,012 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00014 affected6,007 at risk EG00114 affected6,012 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00013 affected6,007 at risk EG0018 affected6,012 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00024 affected6,007 at risk EG00125 affected6,012 at risk
Cardiac Valve Disease	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Cardiac Ventricular Thrombosis	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0005 affected6,007 at risk EG0012 affected6,012 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0012 affected6,012 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Cardiomyopathy Acute	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0014 affected6,012 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Cor Pulmonale	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Coronary Artery Stenosis	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Diastolic Dysfunction	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hypertensive Heart Disease	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Interventricular Septum Rupture	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ischaemic Cardiomyopathy	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0012 affected6,012 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Myocardial Fibrosis	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Myocarditis	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Nodal Rhythm	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pericarditis	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Sinus Node Dysfunction	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0013 affected6,012 at risk
Tachycardia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0010 affected6,012 at risk
Motion Sickness	Ear and labyrinth disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Conjunctival Oedema	Eye disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Exophthalmos	Eye disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Retinal Artery Occlusion	Eye disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Abdominal Incarcerated Hernia	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Acute Abdomen	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ascites	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Chronic Gastritis	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0010 affected6,012 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0012 affected6,012 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0012 affected6,012 at risk
Enterocolitis Haemorrhagic	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Enterovesical Fistula	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Gastric Polyps	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ileus	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pancreatic Disorder	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0012 affected6,012 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Peptic Ulcer Perforation	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Rectal Polyp	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Subileus	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Asthenia	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Chest Pain	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Death	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00025 affected6,007 at risk EG00130 affected6,012 at risk
Fatigue	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Oedema Peripheral	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Peripheral Swelling	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pyrexia	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0013 affected6,012 at risk
Sudden Cardiac Death	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Systemic Inflammatory Response Syndrome	General disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0013 affected6,012 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0012 affected6,012 at risk
Hepatic Lesion	Hepatobiliary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Anaphylactic Reaction	Immune system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Abdominal Abscess	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Abscess Limb	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Anal Abscess	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Breast Cellulitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Bronchitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0005 affected6,007 at risk EG0013 affected6,012 at risk
Bronchopulmonary Aspergillosis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Cellulitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG00011 affected6,007 at risk EG00110 affected6,012 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Clostridium Difficile Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Diverticulitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Empyema	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Endocarditis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Endocarditis Bacterial	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Endophthalmitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Endotoxic Shock	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Erysipelas	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0014 affected6,012 at risk
Fungal Oesophagitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Fungal Skin Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0013 affected6,012 at risk
Gastroenteritis Salmonella	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Haematoma Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Helicobacter Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Infectious Colitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Infectious Pleural Effusion	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Infective Exacerbation of Bronchiectasis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Infective Exacerbation of Chronic Obstructive Airways Disease	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0014 affected6,012 at risk
Infective Spondylitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Influenza	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Injection Site Abscess	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Intervertebral Discitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Lung Abscess	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Lung Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Mediastinitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Parotitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pneumonia	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG00058 affected6,007 at risk EG00148 affected6,012 at risk
Pneumonia Bacterial	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0014 affected6,012 at risk
Pneumonia Pseudomonal	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pneumonia Staphylococcal	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pulmonary Sepsis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Pyelonephritis Chronic	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Pyoderma	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0013 affected6,012 at risk
Sepsis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0013 affected6,012 at risk
Septic Shock	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0014 affected6,012 at risk
Sinusitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Soft Tissue Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Splenic Abscess	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Systemic Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Tracheobronchitis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Tuberculous Pleurisy	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Urinary Tract Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG00011 affected6,007 at risk EG00111 affected6,012 at risk
Urinary Tract Infection Bacterial	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Urosepsis	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0014 affected6,012 at risk
Viral Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Wound Infection	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Wound Infection Staphylococcal	Infections and infestations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0013 affected6,012 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Intestinal Anastomosis Complication	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Multiple Injuries	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Nerve Injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Procedural Pneumothorax	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Tendon Injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Toxicity to Various Agents	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Traumatic Lung Injury	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Twiddler's Syndrome	Injury, poisoning and procedural complications	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Aspiration Bronchial	Investigations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Body Temperature Increased	Investigations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Cardiac Output Decreased	Investigations	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Myocardial Necrosis Marker Increased	Investigations	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0013 affected6,012 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Diabetic Metabolic Decompensation	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Failure to Thrive	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0015 affected6,012 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Overweight	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Compartment Syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0013 affected6,012 at risk
Vertebral Lesion	Musculoskeletal and connective tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Acute Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Bladder Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Breast Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hepatic Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Lung Infiltration Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0015 affected6,012 at risk
Malignant Neoplasm of Unknown Primary Site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Malignant Pleural Effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Mediastinum Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Metastatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Non-Small Cell Lung Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Plasma Cell Myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Rectal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Rectosigmoid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Squamous Cell Carcinoma of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Aphasia	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Carotid Artery Occlusion	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Craniocervical Syndrome	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Demyelinating Polyneuropathy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Epilepsy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Facial Paralysis	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Headache	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Hypoglycaemic Coma	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hypoglycaemic Encephalopathy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Orthostatic Intolerance	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Presyncope	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Sciatica	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Seizure	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Syncope	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0006 affected6,007 at risk EG0015 affected6,012 at risk
Vascular Encephalopathy	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Vertebral Artery Stenosis	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Vertigo CNS Origin	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Device Dislocation	Product Issues	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Device Failure	Product Issues	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Device Occlusion	Product Issues	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Anxiety	Psychiatric disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Conversion Disorder	Psychiatric disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Panic Attack	Psychiatric disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0007 affected6,007 at risk EG0018 affected6,012 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Ketonuria	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Nephritis	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Nephrotic Syndrome	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Renal Failure	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0013 affected6,012 at risk
Renal Impairment	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Urinary Retention	Renal and urinary disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0010 affected6,012 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0011 affected6,012 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0007 affected6,007 at risk EG0019 affected6,012 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0008 affected6,007 at risk EG0013 affected6,012 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0013 affected6,012 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00081 affected6,007 at risk EG00177 affected6,012 at risk
Chronic Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0004 affected6,007 at risk EG0010 affected6,012 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0015 affected6,012 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Interstitial Lung Disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Lupus Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pickwickian Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0013 affected6,012 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0003 affected6,007 at risk EG0010 affected6,012 at risk
Pneumothorax Spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pulmonary Arterial Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Pulmonary Mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0014 affected6,012 at risk
Pulmonary Pneumatocele	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0011 affected6,012 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0009 affected6,007 at risk EG0018 affected6,012 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0010 affected6,012 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Diabetic Foot	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Skin Necrosis	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Vasculitic Ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Bereavement	Social circumstances	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Immobile	Social circumstances	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Hospitalisation	Surgical and medical procedures	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Aortic Dissection	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Aortic Stenosis	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0002 affected6,007 at risk EG0011 affected6,012 at risk
Arterial Stenosis	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Distributive Shock	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Hypertension	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0012 affected6,012 at risk
Hypertensive Crisis	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0013 affected6,012 at risk
Hypotension	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0005 affected6,007 at risk EG0013 affected6,012 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Peripheral Artery Occlusion	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk
Peripheral Artery Thrombosis	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0012 affected6,012 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0000 affected6,007 at risk EG0011 affected6,012 at risk
Post Thrombotic Syndrome	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG0001 affected6,007 at risk EG0010 affected6,012 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00069 affected6,007 at risk EG00152 affected6,012 at risk
Headache	Nervous system disorders	MedDRA Version 20.1	Non-systematic Assessment	EG000114 affected6,007 at risk EG001147 affected6,012 at risk
Hypertension	Vascular disorders	MedDRA Version 20.1	Non-systematic Assessment	EG00075 affected6,007 at risk EG00193 affected6,012 at risk

Certain Agreements

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D016769	Embolism and Thrombosis

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D006333	Heart Failure
D012131	Respiratory Insufficiency
D020521	Stroke
D003141	Communicable Diseases
D012216	Rheumatic Diseases
D013923	Thromboembolism

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds