A Study of Tocilizumab in Comparison to Etanercept in Par... | NCT01331837

NCT01331837

ID	Type	Description	Link
2010-020065-24	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
Etanercept	Active Comparator		Drug: Etanercept
Tocilizumab	Experimental		Drug: Tocilizumab

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.	Etanercept

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event	Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.	From baseline up to 4.9 years
Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event	Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke	From baseline up to 4.9 years
Time to First CV-EAC Adjudicated Event - Sensitivity Analysis	Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis	From Baseline up to 4.9 years
Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis	Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis	From Baseline up to 4.9 years
Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis	Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses

Secondary Outcomes

Measure	Description	Time Frame
The Time to First Occurrence of an Expanded CV Composite Endpoint	Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.	From baseline up to 4.9 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants with moderate to severe RA of greater than or equal to (>=6) months duration
Inadequate response to at least one non-biologic DMARD
Positive for Rheumatoid Factor (RF) and/or anti-cyclic citrullinated peptide (CCP) antibodies at screening
Have C-reactive protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL) at screening or at the baseline visit
Swollen joint count (SJC) >=8 (66 joint count) and tender joint count (TJC) >= 8 (68 joint count) during screening or at the baseline visit
History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >= 4 weeks

Exclusion Criteria:

Major surgery (including joint surgery or coronary revascularization) within 8 weeks prior to screening or planned major surgery within 1 year of study start
Rheumatic autoimmune disease other than RA
History of or current inflammatory joint disease other than RA
Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (myocardial infarction, revascularization, stroke, transient ischemic attack, or acute coronary syndrome)
Current or previous (within the past 2 years) evidence of serious uncontrolled concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease
Uncontrolled disease states, such as asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
Pre-existing central nervous system demyelinating or seizure disorders
History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion
Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds
Any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit
Active tuberculosis (TB) requiring treatment within 3 years prior to baseline
Latent TB diagnosed during screening that has not been appropriately treated
Primary or secondary immunodeficiency (history of or currently active)
Moderate to severe heart failure
Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
Breast feeding mothers
History of alcohol, drug or chemical abuse within the 6 months prior to screening
Participants with lack of peripheral venous access
Participants with a history of allergic reactions to latex
Previous treatment with non-tumor necrosis factor (non-TNF)-inhibitor biologic therapy
Treatment with any investigational agent within 4 weeks of screening visit
Treatment with any cell depleting therapies within 1 year of baseline
Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline visit
Immunization with a live/attenuated vaccine within 4 weeks prior to baseline visit
Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Uni Of Alabama,Birmingham; Medicine - Rheumatology		Birmingham	Alabama	35294	United States
Rheumatology Associates of North Alabama

PubMed Identifier	Type	Citation	Retractions
31469238	Derived	Giles JT, Sattar N, Gabriel S, Ridker PM, Gay S, Warne C, Musselman D, Brockwell L, Shittu E, Klearman M, Fleming TR. Cardiovascular Safety of Tocilizumab Versus Etanercept in Rheumatoid Arthritis: A Randomized Controlled Trial. Arthritis Rheumatol. 2020 Jan;72(1):31-40. doi: 10.1002/art.41095.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
FG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event

Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.

Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG0001538 OG0011542

Title

Denominators

Categories

Title	Measurements
	OG000NA(NA to NA)Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event OG001NA(NA to NA)Median time to event and 95% confidence intervals could not be estimated due to less than 50% of patients experiencing an event

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	The analysis assessed in the ITT population the hazard ratio of the primary endpoint in TCZ compared to ETA patients. This was done through a comparison of the hazard functions between TCZ and ETA patients. A stratified Cox proportional hazards regression model was used in evaluating the relative CV event rate of TCZ over ETA, with the following randomization factors used as strata: Previous exposure to anti-TNF (Yes/No) History of CV events (Yes/No)					Hazard Ratio (HR)	1.05			2-Sided	95	0.77	1.43					Non-Inferiority or Equivalence	In order to reject the null hypothesis and claim non-inferiority of TCZ compared to ETA, a HR point estimate of ≤ 1.278 and upper limit of 95% CI <1.8 was required.

Primary

Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event

Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke

Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication

Posted

Number

Percentage of patients with event

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Time to First CV-EAC Adjudicated Event - Sensitivity Analysis

Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.

Posted

Median

95% Confidence Interval

Months

From Baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis

Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis

Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.

Posted

Number

Percentage of patients with event

From Baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis

Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses

Analysis was conducted on the ITT population

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis

Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses

Analysis was conducted on the ITT population

Posted

Number

Percentage of patients with event

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date

Analysis was conducted on the ITT population

Posted

Median

95% Confidence Interval

Months

From Baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date

Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).

Analysis was conducted on the ITT population

Posted

Number

Percentage of participants with event

From Baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

The Time to First Occurrence of an Expanded CV Composite Endpoint

Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.

Analysis was conducted on the ITT population.

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Percentages of Participants With an Expanded CV Composite Endpoint

Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.

Analysis was conducted on the ITT population.

Posted

Number

Percentages of participants

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction

Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction

Anlysis was conducted on the ITT population.

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction

Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction

Anlysis was conducted on the ITT population

Posted

Number

Percentage of patients

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death

Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death

Analysis was conducted on the ITT population

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death

Percentage of patients reporting Individual component of primary endpoint: cardiovascular death

Analysis was conducted on the ITT population

Posted

Number

Percentage of patients

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke

Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke

Analysis was conducted on the ITT population

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke

Analysis was conducted on the ITT population

Posted

Number

Percentage of patients

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality

Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality

Analysis was conducted on the ITT population.

Posted

Median

95% Confidence Interval

Months

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality

Percentage of patients reporting Individual component of primary endpoint: All-cause mortality

Analysis was conducted on the ITT population.

Posted

Number

Percentage of patients

From baseline up to 4.9 years

ID	Title	Description
OG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
OG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0009 affected1,542 at risk EG0015 affected1,538 at risk
AUTOIMMUNE HAEMOLYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GRANULOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0011 affected1,538 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0009 affected1,542 at risk EG0017 affected1,538 at risk
ADAMS-STOKES SYNDROME	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0018 affected1,538 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0007 affected1,542 at risk EG0014 affected1,538 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG00018 affected1,542 at risk EG00114 affected1,538 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
BRADYARRHYTHMIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BRADYCARDIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0011 affected1,538 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG00111 affected1,538 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0008 affected1,542 at risk EG0017 affected1,538 at risk
CARDIAC FIBRILLATION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0014 affected1,538 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0019 affected1,538 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MITRAL VALVE STENOSIS	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG00015 affected1,542 at risk EG00110 affected1,538 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
PALPITATIONS	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
POSTINFARCTION ANGINA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SILENT MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
SINOATRIAL BLOCK	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
TACHYCARDIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
ATRIAL SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYDROCELE	Congenital, familial and genetic disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DEAFNESS UNILATERAL	Ear and labyrinth disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
GOITRE	Endocrine disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CATARACT	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
CORNEAL PERFORATION	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
KERATITIS	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RETINAL ARTERY OCCLUSION	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SCLERITIS	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ULCERATIVE KERATITIS	Eye disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
ABDOMINAL ADHESIONS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0013 affected1,538 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
ACID PEPTIC DISEASE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ASCITES	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
COLITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DIAPHRAGMATIC HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0012 affected1,538 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0016 affected1,538 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
FEMORAL HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GASTRIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0014 affected1,538 at risk
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0014 affected1,538 at risk
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GASTROINTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INCARCERATED HIATUS HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
INCARCERATED UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
LARGE INTESTINAL STENOSIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0014 affected1,538 at risk
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MELAENA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
NAUSEA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PALATAL DISORDER	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0014 affected1,538 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0015 affected1,538 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PEPTIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RETROPERITONEAL FIBROSIS	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
VOMITING	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CHEST PAIN	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG00010 affected1,542 at risk EG0013 affected1,538 at risk
COMPLICATION ASSOCIATED WITH DEVICE	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEATH	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0013 affected1,538 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
IMPAIRED HEALING	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LOCAL SWELLING	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0015 affected1,538 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PAIN	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PYREXIA	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0013 affected1,538 at risk
SUDDEN DEATH	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0013 affected1,538 at risk
SWELLING	General disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG00114 affected1,538 at risk
HEPATIC VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
POST CHOLECYSTECTOMY SYNDROME	Hepatobiliary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OVERLAP SYNDROME	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SARCOIDOSIS	Immune system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ABSCESS LIMB	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0016 affected1,538 at risk
ABSCESS ORAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ABSCESS RUPTURE	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ANAL ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
APPENDICITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0019 affected1,538 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
ASPERGILLUS INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
BILIARY SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BRONCHITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0015 affected1,538 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BURSITIS INFECTIVE	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
CELLULITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0008 affected1,542 at risk EG00124 affected1,538 at risk
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CELLULITIS STREPTOCOCCAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CERVICITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CHRONIC TONSILLITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLONIC ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DENGUE FEVER	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
DEVICE RELATED SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DISSEMINATED TUBERCULOSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
DIVERTICULITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG00110 affected1,538 at risk
EMPYEMA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ENDOPHTHALMITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ENTERITIS INFECTIOUS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
EPIDIDYMITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
EPIGLOTTITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
ERYSIPELAS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG00111 affected1,538 at risk
ESCHERICHIA PYELONEPHRITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
FUNGAL SKIN INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GASTROENTERITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0013 affected1,538 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
GROIN ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HAEMATOMA INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HAEMOPHILUS SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HERPANGINA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HERPES ZOSTER	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0012 affected1,538 at risk
INFECTED DERMAL CYST	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
INFECTIOUS COLITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0013 affected1,538 at risk
INFECTIVE ANEURYSM	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INFLUENZA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
INJECTION SITE ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
LUDWIG ANGINA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LUNG ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LUNG INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LUNG INFECTION PSEUDOMONAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MASTOIDITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MENINGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
MUSCLE ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
NASAL ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
NEUROSYPHILIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
OPHTHALMIC HERPES SIMPLEX	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
OPHTHALMIC HERPES ZOSTER	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
OSTEOMYELITIS CHRONIC	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PAPILLOMA VIRAL INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PERIHEPATIC ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PERITONITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PHARYNGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMONIA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG00041 affected1,542 at risk EG00147 affected1,538 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PNEUMONIA INFLUENZAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMONIA MYCOPLASMAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0011 affected1,538 at risk
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PULMONARY TUBERCULOMA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0015 affected1,538 at risk
RECTAL ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
SALPINGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SCROTAL ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0007 affected1,542 at risk EG0016 affected1,538 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0013 affected1,538 at risk
SINUSITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0012 affected1,538 at risk
TONGUE ABSCESS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TONSILLITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
TOXIC SHOCK SYNDROME STREPTOCOCCAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
TRACHEITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TUBERCULOSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG00012 affected1,542 at risk EG0017 affected1,538 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
UROSEPSIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
VIRAL INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
VIRAL PHARYNGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
WEST NILE VIRAL INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
WOUND INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ACCIDENT AT WORK	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COMMINUTED FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
DISLOCATION OF VERTEBRA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
FALL	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0010 affected1,538 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0015 affected1,538 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
FRACTURE DISPLACEMENT	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GUN SHOT WOUND	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG00012 affected1,542 at risk EG0014 affected1,538 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0013 affected1,538 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0013 affected1,538 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LIGAMENT INJURY	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PNEUMOTHORAX TRAUMATIC	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
POST PROCEDURAL FISTULA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
RESPIRATORY FUME INHALATION DISORDER	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0011 affected1,538 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
STOMAL HERNIA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
STRESS FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SUBCUTANEOUS HAEMATOMA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
SYNOVIAL RUPTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
EOSINOPHIL COUNT INCREASED	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HAEMATOCRIT ABNORMAL	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HAEMOGLOBIN ABNORMAL	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
STAPHYLOCOCCUS TEST POSITIVE	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SYNOVIAL FLUID WHITE BLOOD CELLS POSITIVE	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TROPONIN INCREASED	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0015 affected1,538 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DIABETIC COMPLICATION	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0010 affected1,538 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0010 affected1,538 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
FASCIITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
FINGER DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
FISTULA	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0012 affected1,538 at risk
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0015 affected1,538 at risk
KNEE DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LIMB DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MORPHOEA	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG00022 affected1,542 at risk EG00114 affected1,538 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0012 affected1,538 at risk
OSTEONECROSIS OF JAW	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OSTEOPOROTIC FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PERIARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG00015 affected1,542 at risk EG00112 affected1,538 at risk
RHEUMATOID NODULE	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SYNOVIAL CYST	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
TENOSYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
ANAL SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
BENIGN ANORECTAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BENIGN NEOPLASM OF CERVIX UTERI	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0013 affected1,538 at risk
CARCINOID TUMOUR OF THE GASTROINTESTINAL TRACT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CARCINOID TUMOUR PULMONARY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CARDIAC MYXOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CENTRAL NERVOUS SYSTEM LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CEREBRAL HAEMANGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CHOLANGIOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLON CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COLORECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DIFFUSE LARGE B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ENDOMETRIAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GLIOBLASTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HAEMANGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INTESTINAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INTRADUCTAL PROLIFERATIVE BREAST LESION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0013 affected1,538 at risk
LUNG ADENOCARCINOMA STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0012 affected1,538 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0013 affected1,538 at risk
MALIGNANT MELANOMA STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MARJOLIN'S ULCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
METASTATIC GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OVARIAN ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OVARIAN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PANCREATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PAPILLARY THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PARAPROTEINAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PHARYNGEAL NEOPLASM BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PITUITARY TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PLASMA CELL MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0013 affected1,538 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SQUAMOUS CELL CARCINOMA OF LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SQUAMOUS CELL CARCINOMA OF THE TONGUE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SQUAMOUS ENDOMETRIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
THYROID ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
TUMOUR INVASION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
AMYOTROPHIC LATERAL SCLEROSIS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BALANCE DISORDER	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BRAIN STEM INFARCTION	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CAROTID ARTERY DISEASE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0008 affected1,542 at risk EG00114 affected1,538 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
CERVICAL CORD COMPRESSION	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CERVICAL RADICULOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
COMA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DEMENTIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DIABETIC COMA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DYSARTHRIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DYSKINESIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
EPILEPSY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
FACIAL PARALYSIS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
GENERALISED TONIC-CLONIC SEIZURE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HEMIPARESIS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
INTRACRANIAL ANEURYSM	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0005 affected1,542 at risk EG0015 affected1,538 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MIGRAINE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MYASTHENIA GRAVIS	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PARAESTHESIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PRESYNCOPE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
REVERSIBLE ISCHAEMIC NEUROLOGICAL DEFICIT	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
RUPTURED CEREBRAL ANEURYSM	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SCIATICA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
SEIZURE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
SYNCOPE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TRANSIENT GLOBAL AMNESIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0019 affected1,538 at risk
VASCULAR DEMENTIA	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEVICE BREAKAGE	Product Issues	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DEVICE DISLOCATION	Product Issues	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0013 affected1,538 at risk
DEVICE FAILURE	Product Issues	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEVICE LOOSENING	Product Issues	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BURNOUT SYNDROME	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DELIRIUM	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DELIRIUM TREMENS	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DEPRESSION	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MENTAL DISORDER	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SCHIZOAFFECTIVE DISORDER BIPOLAR TYPE	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0005 affected1,542 at risk EG0013 affected1,538 at risk
CALCULUS BLADDER	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CALCULUS URINARY	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
END STAGE RENAL DISEASE	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
GLOMERULONEPHRITIS CHRONIC	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0013 affected1,538 at risk
OBSTRUCTIVE NEPHROPATHY	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PELVI-URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0012 affected1,538 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
URETEROLITHIASIS	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ACQUIRED PHIMOSIS	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BREAST FIBROSIS	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CERVICAL DYSPLASIA	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CERVICAL POLYP	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
GENITAL PROLAPSE	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
OVARIAN CYST	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0010 affected1,538 at risk
OVARIAN CYST TORSION	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RECTOCELE	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SPERMATOCELE	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
UTERINE PROLAPSE	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
VAGINAL HAEMATOMA	Reproductive system and breast disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ALVEOLITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0005 affected1,542 at risk EG0012 affected1,538 at risk
ASTHMATIC CRISIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BRONCHIAL OBSTRUCTION	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
BRONCHOSTENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0007 affected1,542 at risk EG00110 affected1,538 at risk
CHRONIC RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0015 affected1,538 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYDROTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0015 affected1,538 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0005 affected1,542 at risk EG0016 affected1,538 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG00011 affected1,542 at risk EG0011 affected1,538 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
PULMONARY GRANULOMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PULMONARY MASS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PULMONARY SARCOIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PULMONARY THROMBOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
BLISTER	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DERMAL CYST	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPERSENSITIVITY VASCULITIS	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
PEMPHIGOID	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SKIN DISORDER	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SKIN NECROSIS	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0012 affected1,538 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0014 affected1,538 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0010 affected1,538 at risk
VASCULITIC ULCER	Skin and subcutaneous tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
ABDOMINAL HERNIA REPAIR	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ANAL FISTULA EXCISION	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ANGIOPLASTY	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
APPENDICECTOMY	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CARDIAC PACEMAKER REPLACEMENT	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
COLOSTOMY CLOSURE	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
IMPLANTABLE DEFIBRILLATOR INSERTION	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
KNEE ARTHROPLASTY	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
LARGE INTESTINE ANASTOMOSIS	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
MITRAL VALVE REPLACEMENT	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SEQUESTRECTOMY	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
UMBILICAL HERNIA REPAIR	Surgical and medical procedures	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0004 affected1,542 at risk EG0013 affected1,538 at risk
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
AORTIC CALCIFICATION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0008 affected1,542 at risk EG0016 affected1,538 at risk
EMBOLISM ARTERIAL	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
FEMORAL ARTERY EMBOLISM	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HAEMATOMA	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPERTENSION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0006 affected1,542 at risk EG0014 affected1,538 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
HYPOTENSION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
INFARCTION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0011 affected1,538 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0002 affected1,542 at risk EG0013 affected1,538 at risk
PERIPHERAL VENOUS DISEASE	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
RHEUMATOID VASCULITIS	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
SUBCLAVIAN ARTERY OCCLUSION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk
THROMBOSIS	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0012 affected1,538 at risk
VARICOSE VEIN	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0011 affected1,538 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG0000 affected1,542 at risk EG0011 affected1,538 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA version 19.0	Non-systematic Assessment	EG0003 affected1,542 at risk EG0011 affected1,538 at risk
MANIA	Psychiatric disorders	MedDRA version 19.0	Non-systematic Assessment	EG0001 affected1,542 at risk EG0010 affected1,538 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG00021 affected1,542 at risk EG00185 affected1,538 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA version 19.0	Non-systematic Assessment	EG00033 affected1,542 at risk EG00192 affected1,538 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG00084 affected1,542 at risk EG001140 affected1,538 at risk
BRONCHITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG000185 affected1,542 at risk EG001244 affected1,538 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG000141 affected1,542 at risk EG001239 affected1,538 at risk
PHARYNGITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG00076 affected1,542 at risk EG001113 affected1,538 at risk
SINUSITIS	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG00078 affected1,542 at risk EG00188 affected1,538 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG000193 affected1,542 at risk EG001243 affected1,538 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA version 19.0	Non-systematic Assessment	EG000150 affected1,542 at risk EG001174 affected1,538 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA version 19.0	Non-systematic Assessment	EG00044 affected1,542 at risk EG001120 affected1,538 at risk
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA version 19.0	Non-systematic Assessment	EG00052 affected1,542 at risk EG001143 affected1,538 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG000106 affected1,542 at risk EG001143 affected1,538 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG00092 affected1,542 at risk EG001147 affected1,538 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA version 19.0	Non-systematic Assessment	EG000132 affected1,542 at risk EG001152 affected1,538 at risk
HEADACHE	Nervous system disorders	MedDRA version 19.0	Non-systematic Assessment	EG00068 affected1,542 at risk EG001103 affected1,538 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA version 19.0	Non-systematic Assessment	EG00076 affected1,542 at risk EG001127 affected1,538 at risk
HYPERTENSION	Vascular disorders	MedDRA version 19.0	Non-systematic Assessment	EG000158 affected1,542 at risk EG001200 affected1,538 at risk

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D007127	Immunoglobulin Constant Regions
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins
D018124	Receptors, Tumor Necrosis Factor
D018121	Receptors, Cytokine
D011971	Receptors, Immunologic
D011956	Receptors, Cell Surface
D008565	Membrane Proteins

ID	Title	Description
BG000	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
BG001	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Etanercept	Participants received 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.			422	1,542	910	1,542
EG001	Tocilizumab	Participants received 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.			479	1,538	1,090	1,538