A Phase III Study of Apixaban in Patients With Atrial Fib... | NCT00496769

Name	Class
Pfizer	INDUSTRY

Label	Type	Description	Intervention Names
Apixaban	Experimental		Drug: Apixaban
Acetylasalicylic acid	Active Comparator		Drug: Acetylsalicylic acid

Name	Type	Description	Arm Group Labels	Other Names
Apixaban	Drug	Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

Measure	Description	Time Frame
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period	Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)	Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Measure	Description	Time Frame
Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period	Event rate=percent of participants with an event divided by the total participants in the arm.	Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Male and female
Age of 50 years or older
Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
At least 1 of the following risk factors for stroke:
- Prior stroke or transient ischemic attack
- Age of 75 years or older
- Arterial hypertension on treatment
- Diabetes mellitus
- Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
- Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
- Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:
- Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
- Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

Women who are pregnant or breast feeding
Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
Valvular disease requiring surgery
Planned ablation procedure for atrial fibrillation to be performed within 3 months
Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:
- Active peptic ulcer disease
- Platelet count <100,000/mm^3 or hemoglobin <10g/dL
- Recent stroke (within 10 days)
- Documented hemorrhagic tendencies or blood dyscrasias
Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
Severe comorbid condition with life expectancy <1 year
Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
Allergy or adverse reaction to acetylsalicylic acid
Required treatment with a thienopyridine (clopidogrel or ticlopidine)
Prisoners or participants who are compulsory detained (involuntarily incarcerated)
Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
Patients who are compulsorily detained for treatment for a psychiatric or physical illness

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mobile Heart Specialists, Pc		Mobile	Alabama	36608	United States
Southwest Heart

PubMed Identifier	Type	Citation	Retractions
35570249	Derived	Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
35224730	Derived

Label	URL
BMS Clinical Trial Patient Recruiting	View source

ID	Title	Description
FG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

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

Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)

Participants who received at least 1 dose of study drug.

Posted

Number

Percentage of events

Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion

Units	Counts
Participants	OG0002807 OG0012791

Title

Denominators

Categories

Title	Measurements
	OG0001.62 OG0013.63

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		Log Rank		<0.00001		Hazard Ratio (HR)	0.45			2-Sided	95	0.32	0.62					Superiority

Secondary

Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm.

Participants who received at least 1 dose of study drug.

Posted

Number

Percentage of events per year

Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death

Event rate=percent of participants with an event divided by the total participants in the arm.

Participants who received at least 1 dose of study drug.

Posted

Number

Percentage of events per year

Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period

Event rate=percent of participants with an event divided by the total participants in the arm.

Participants who received at least 1 dose of study drug.

Posted

Number

Percentage of events per year

First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period

Event rate=percent of participants with an event divided by the total participants in the arm.

Participants who received at least 1 dose of study drug.

Posted

Number

Percentage of events per year

Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Participants who received at least 1 dose of study drug.

Posted

Number

Participants

First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
OG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality

BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.

Participants who received at least 1 dose of study drug. n=number evaluable

Posted

Number

Participants

First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN

Participants who received at least 1 dose of study drug. n=number evaluable

Posted

Number

Participants

First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Secondary

Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)

ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.

Participants who received at least 1 dose of study drug. n=number evaluable

Posted

Number

Participants

First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

ID	Title	Description
OG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria. Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00011 affected2,798 at risk EG00119 affected2,780 at risk EG00225 affected3,275 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Anxiety	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Atrial flutter	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected2,798 at risk EG0016 affected2,780 at risk EG0028 affected3,275 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0009 affected2,798 at risk EG0011 affected2,780 at risk EG00210 affected3,275 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0007 affected2,798 at risk EG0017 affected2,780 at risk EG00215 affected3,275 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00060 affected2,798 at risk EG00176 affected2,780 at risk EG002116 affected3,275 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0025 affected3,275 at risk
Cataract operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Cerebral infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0016 affected2,780 at risk EG00210 affected3,275 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG00016 affected2,798 at risk EG00124 affected2,780 at risk EG00228 affected3,275 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0016 affected2,780 at risk EG0024 affected3,275 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Chronic sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Dementia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Dengue fever	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG00110 affected2,780 at risk EG0026 affected3,275 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0016 affected2,780 at risk EG00216 affected3,275 at risk
Eye haemorrhage	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Fasciotomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Gait disturbance	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Gallbladder operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Genitourinary operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Haemorrhoid operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hepatitis C	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hypertensive crisis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected2,798 at risk EG0013 affected2,780 at risk EG0023 affected3,275 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected2,798 at risk EG0013 affected2,780 at risk EG00212 affected3,275 at risk
Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Intermittent claudication	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0026 affected3,275 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Lethargy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Lobar pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Loss of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0015 affected2,780 at risk EG00215 affected3,275 at risk
Malaise	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Non-Hodgkin's lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0026 affected3,275 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Panic attack	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Papilloma excision	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Peripheral nerve palsy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Postoperative wound infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected2,798 at risk EG0019 affected2,780 at risk EG0020 affected3,275 at risk
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0012 affected2,780 at risk EG00212 affected3,275 at risk
Skin graft	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Tremor	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Wound infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Abdominoplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Arteriosclerosis obliterans	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Atrioventricular block	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0023 affected3,275 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Blood magnesium decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0014 affected2,780 at risk EG00211 affected3,275 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Bronchopneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0015 affected2,780 at risk EG0020 affected3,275 at risk
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Cerebral haemorrhage traumatic	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Colitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Conduction disorder	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Confusional state	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0016 affected2,780 at risk EG0022 affected3,275 at risk
Device pacing issue	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Dysuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0016 affected2,780 at risk EG0023 affected3,275 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Gout	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hepatic amoebiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0025 affected3,275 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Implant site effusion	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Influenza	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0026 affected3,275 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0027 affected3,275 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Meningitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Migraine	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Omentum neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Parkinson's disease	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0014 affected2,780 at risk EG0024 affected3,275 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Prostatic obstruction	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Prostatic operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0016 affected2,780 at risk EG0026 affected3,275 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Retinal artery occlusion	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Skin infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Tarsal tunnel decompression	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Thrombophlebitis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Tracheitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Abscess limb	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Activities of daily living impaired	Social circumstances	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Allergic bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Amoebic dysentery	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG00012 affected2,798 at risk EG00111 affected2,780 at risk EG00223 affected3,275 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00072 affected2,798 at risk EG00170 affected2,780 at risk EG002113 affected3,275 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0027 affected3,275 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0011 affected2,780 at risk EG00210 affected3,275 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00012 affected2,798 at risk EG0019 affected2,780 at risk EG00224 affected3,275 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Device lead damage	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00013 affected2,798 at risk EG00111 affected2,780 at risk EG00222 affected3,275 at risk
Embolic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0016 affected2,780 at risk EG00212 affected3,275 at risk
Femoral artery embolism	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Generalised oedema	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0026 affected3,275 at risk
Haemorrhage	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0026 affected3,275 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hernia pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Hysterectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Implantable defibrillator replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lung infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Lymphocele	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Partial seizures	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Peripheral artery angioplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Peripheral embolism	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Physical assault	Social circumstances	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Post procedural diarrhoea	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Presyncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Psoas abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected2,798 at risk EG0011 affected2,780 at risk EG0028 affected3,275 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Renal impairment	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Renal infarct	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0019 affected2,780 at risk EG0025 affected3,275 at risk
Retinal detachment	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Sciatica	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Sinoatrial block	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Starvation	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Subileus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Sudden cardiac death	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0011 affected2,780 at risk EG0026 affected3,275 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0015 affected2,780 at risk EG0021 affected3,275 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Therapeutic embolisation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Transfusion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Venous insufficiency	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Vertebroplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Viral infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0020 affected3,275 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0016 affected2,780 at risk EG0027 affected3,275 at risk
Aortic rupture	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Arthritis bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0011 affected2,780 at risk EG0029 affected3,275 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Biliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Bladder mass	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Cardiac death	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0012 affected2,780 at risk EG0029 affected3,275 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0013 affected2,780 at risk EG0024 affected3,275 at risk
Carditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cervical root pain	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Coronary artery disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0016 affected2,780 at risk EG00216 affected3,275 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cystoscopy	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0007 affected2,798 at risk EG0015 affected2,780 at risk EG00211 affected3,275 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Ear disorder	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Ejection fraction decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Endocarditis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Epilepsy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0020 affected3,275 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0008 affected2,798 at risk EG0015 affected2,780 at risk EG00214 affected3,275 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0019 affected2,780 at risk EG00220 affected3,275 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
General physical health deterioration	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0014 affected2,780 at risk EG00213 affected3,275 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0019 affected2,780 at risk EG00213 affected3,275 at risk
Ileus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0013 affected2,780 at risk EG0020 affected3,275 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0012 affected2,780 at risk EG0025 affected3,275 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Medical device complication	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Orchidectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0016 affected2,780 at risk EG0023 affected3,275 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG00011 affected2,798 at risk EG0013 affected2,780 at risk EG00217 affected3,275 at risk
Osteomyelitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Paraesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00037 affected2,798 at risk EG00155 affected2,780 at risk EG00299 affected3,275 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Pyelonephritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Pyometra	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected2,798 at risk EG00111 affected2,780 at risk EG0020 affected3,275 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Toe amputation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Tooth extraction	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0014 affected2,780 at risk EG0021 affected3,275 at risk
Urethral disorder	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Venous thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0013 affected2,780 at risk EG0024 affected3,275 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0025 affected3,275 at risk
Angina unstable	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00020 affected2,798 at risk EG00112 affected2,780 at risk EG00217 affected3,275 at risk
Angiogram	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0021 affected3,275 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00039 affected2,798 at risk EG00128 affected2,780 at risk EG00253 affected3,275 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0006 affected2,798 at risk EG0015 affected2,780 at risk EG00213 affected3,275 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Convulsion	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Delirium	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0020 affected3,275 at risk
Dermatitis herpetiformis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0016 affected2,780 at risk EG00211 affected3,275 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Headache	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0028 affected3,275 at risk
Hip surgery	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0022 affected3,275 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0013 affected2,780 at risk EG0026 affected3,275 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0014 affected2,780 at risk EG0024 affected3,275 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00019 affected2,798 at risk EG00146 affected2,780 at risk EG00222 affected3,275 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Lacunar infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Lymph node cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0011 affected2,780 at risk EG0025 affected3,275 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0027 affected3,275 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG00111 affected2,780 at risk EG0027 affected3,275 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Sebaceous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0014 affected2,780 at risk EG0027 affected3,275 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected2,798 at risk EG00129 affected2,780 at risk EG00213 affected3,275 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Uterine dilation and curettage	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Adverse drug reaction	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Amaurosis fugax	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Angioplasty	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Aortic dissection	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Arrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Arterial stenosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Arteriogram coronary	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0013 affected2,780 at risk EG0028 affected3,275 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Chest discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0027 affected3,275 at risk
Clostridium colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0026 affected3,275 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Device malfunction	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Diverticulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0027 affected3,275 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Eye operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Gangrene	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0016 affected2,780 at risk EG0028 affected3,275 at risk
Heart valve operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Localised infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Malignant melanoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Mastectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pelvic mass	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0014 affected2,780 at risk EG0025 affected3,275 at risk
Pneumonia viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Renal cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Renal colic	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0015 affected2,780 at risk EG0026 affected3,275 at risk
Retinal artery embolism	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Salivary gland operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0014 affected2,780 at risk EG00217 affected3,275 at risk
Shock	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Sinusitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Thyroid haemorrhage	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00011 affected2,798 at risk EG00115 affected2,780 at risk EG00224 affected3,275 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0013 affected2,780 at risk EG0026 affected3,275 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Angina pectoris	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0019 affected2,780 at risk EG00214 affected3,275 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Aortic aneurysm	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Aortic stenosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Aphasia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Arteriosclerosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected2,798 at risk EG0013 affected2,780 at risk EG0025 affected3,275 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0013 affected2,780 at risk EG0029 affected3,275 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0015 affected2,780 at risk EG00212 affected3,275 at risk
Basosquamous carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Brain stem infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Bronchiectasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0017 affected2,780 at risk EG00210 affected3,275 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0026 affected3,275 at risk
Carotid arterial embolus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cataract	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0026 affected3,275 at risk
Cerebral cyst	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0025 affected3,275 at risk
Cor pulmonale	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Depression	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0015 affected2,780 at risk EG00211 affected3,275 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0028 affected3,275 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haematoma	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Heart rate irregular	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hernia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0016 affected2,780 at risk EG00212 affected3,275 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0013 affected2,780 at risk EG0025 affected3,275 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Multi-organ failure	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG00011 affected2,798 at risk EG00112 affected2,780 at risk EG00224 affected3,275 at risk
Oedema	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pallor	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0013 affected2,780 at risk EG0022 affected3,275 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0014 affected2,780 at risk EG0022 affected3,275 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0012 affected2,780 at risk EG0023 affected3,275 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0021 affected3,275 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0013 affected2,780 at risk EG0027 affected3,275 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Red blood cell sedimentation rate increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Renal stone removal	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0008 affected2,798 at risk EG00118 affected2,780 at risk EG00226 affected3,275 at risk
Thromboembolectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0011 affected2,780 at risk EG0023 affected3,275 at risk
Urosepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0024 affected3,275 at risk
Varicose vein	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Appendicectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Appendicitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0026 affected3,275 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0022 affected3,275 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Bursal operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0017 affected2,780 at risk EG0023 affected3,275 at risk
Cardioversion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Cerebellar ataxia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG00016 affected2,798 at risk EG00140 affected2,780 at risk EG00215 affected3,275 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0012 affected2,780 at risk EG0024 affected3,275 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Death	General disorders	MedDRA 20.1	Systematic Assessment	EG00014 affected2,798 at risk EG0019 affected2,780 at risk EG00238 affected3,275 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0014 affected2,780 at risk EG0026 affected3,275 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Helicobacter infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hernia repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0011 affected2,780 at risk EG0022 affected3,275 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0005 affected2,798 at risk EG0014 affected2,780 at risk EG00212 affected3,275 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0014 affected2,780 at risk EG0024 affected3,275 at risk
Hypothyroidism	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Incisional hernia repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Left ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0026 affected3,275 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Liver function test abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0012 affected2,780 at risk EG0020 affected3,275 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Microvascular angina	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0015 affected2,780 at risk EG0022 affected3,275 at risk
Oral candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0003 affected2,798 at risk EG0015 affected2,780 at risk EG0023 affected3,275 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0015 affected2,780 at risk EG0023 affected3,275 at risk
Phlebitis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0007 affected2,798 at risk EG00110 affected2,780 at risk EG00212 affected3,275 at risk
Prostatic specific antigen increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Rectal polypectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0013 affected2,780 at risk EG0023 affected3,275 at risk
Right ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Splenic artery aneurysm	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0012 affected2,780 at risk EG0025 affected3,275 at risk
Sudden death	General disorders	MedDRA 20.1	Systematic Assessment	EG0009 affected2,798 at risk EG00112 affected2,780 at risk EG00232 affected3,275 at risk
Swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0020 affected3,275 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected2,798 at risk EG0011 affected2,780 at risk EG0021 affected3,275 at risk
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0011 affected2,780 at risk EG0020 affected3,275 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cognitive disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Dementia alzheimer's type	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Dysarthria	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Dyskinesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hydrocephalus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hyponatraemic encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Myoclonus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Neuritis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Neuroglycopenia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Paraplegia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Seizure	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Simple partial seizures	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Status epilepticus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Subdural effusion	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Vascular dementia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cephalhaematoma	Pregnancy, puerperium and perinatal conditions	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lead dislodgement	Product Issues	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bipolar i disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Completed suicide	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Hallucination	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Insomnia	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Mental disorder	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Stress	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Suicide attempt	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG00224 affected3,275 at risk
Azotaemia	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Postrenal failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Renal haemorrhage	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Prostatic hypoplasia	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Spermatic cord disorder	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pulmonary vascular disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Cardiac assistance device user	Social circumstances	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Aortic aneurysm repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Benign tumour excision	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bladder polypectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cancer surgery	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Choledochoenterostomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Endarterectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Endovenous ablation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Gastric bypass	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Gastrointestinal tube insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Heart valve replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
High frequency ablation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hydronephrosis repair	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Knee operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Laparotomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Liver operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lung operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Medical device implantation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Medical device removal	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Mitral valve replacement	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pancreaticoduodenectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Plastic surgery to the face	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Proctocolectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Skin lesion removal	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Thyroid operation	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tracheostomy	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ureteral stent insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Urethral stent insertion	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Vascular graft	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ventriculo-peritoneal shunt	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Weight loss diet	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Wrist surgery	Surgical and medical procedures	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Unassigned	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected2,798 at risk EG0016 affected2,780 at risk EG0027 affected3,275 at risk
Accelerated hypertension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Aneurysm	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Arterial disorder	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Circulatory collapse	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Hypertensive emergency	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Leriche syndrome	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Peripheral venous disease	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Temporal arteritis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Varicose ulceration	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Varicose vein ruptured	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Venous haemorrhage	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Anaemia megaloblastic	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cardiac asthma	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cardiac disorder	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Defect conduction intraventricular	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Mitral valve disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Nodal rhythm	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pericarditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Rheumatic heart disease	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Sinus arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG00218 affected3,275 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Liddle's syndrome	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Goitre	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Thyroid mass	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Eye pain	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Eyelid ptosis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Keratitis	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tolosa-hunt syndrome	Eye disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ascites	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Oesophageal dilatation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Proctitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG00214 affected3,275 at risk
Volvulus	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Exercise tolerance decreased	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Incarcerated hernia	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0025 affected3,275 at risk
Peripheral swelling	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Unevaluable event	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hepatitis fulminant	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal wall infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Colonic abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cystitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Diabetic foot infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Empyema	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Encephalitis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Endophthalmitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Erysipelas	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0028 affected3,275 at risk
Escherichia infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Groin infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hepatitis E	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Listeriosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Liver abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Nasopharyngitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Nosocomial infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Orchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Peritonitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Prostate infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Sepsis syndrome	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Staphylococcal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tracheobronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tuberculosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tuberculous pleurisy	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Aortic injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0025 affected3,275 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Arthroscopy	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Blood creatinine increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ecg signs of myocardial ischaemia	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Haemoglobin decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Heart rate abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Liver function test increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Platelet count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diabetes with hyperosmolarity	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Inguinal mass	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
B-cell small lymphocytic lymphoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Carcinoid tumour of the caecum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Intraocular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Leiomyosarcoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Light chain disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Paraneoplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0023 affected3,275 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Vocal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Balance disorder	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0024 affected3,275 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0022 affected3,275 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected2,798 at risk EG0010 affected2,780 at risk EG0021 affected3,275 at risk

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

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Title	Description
BG000	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
BG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
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	Apixaban, 2.5 or 5 mg Twice Daily	Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.	111	2,798	657	2,798	207	2,798
EG001	Acetylsalicylic Acid, 81-324 mg Once Daily	Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.	140	2,780	804	2,780	267	2,780
EG002	Open Label Apixaban	Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.	286	3,275	1,228	3,275	180	3,275