Non-vitamin K Antagonist Oral Anticoagulants in Patients... | NCT02618577

ID	Type	Description	Link
2015-003997-33	EudraCT Number

Name	Class
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company	INDUSTRY
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)	OTHER

Label	Type	Description	Intervention Names
Edoxaban	Experimental	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	Drug: Edoxaban
ASA or Placebo	Active Comparator	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator	Drug: ASA

Name	Type	Description	Arm Group Labels	Other Names
Edoxaban	Drug	Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF	Edoxaban

Measure	Description	Time Frame
Composite of Stroke, Systemic Embolism, or Cardiovascular Death	Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.	28 months

Measure	Description	Time Frame
Components of the Primary Outcome, Stroke	Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure.	28 months
Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)

Name	Affiliation	Role
Paulus Kirchhof, Prof. Dr.	University Clinic of Hamburg-Eppendorf, Hamburg, Germany	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Several Sites		Multiple Locations			Austria
Several Sites

PubMed Identifier	Type	Citation	Retractions
31377792	Background	Bertaglia E, Blank B, Blomstrom-Lundqvist C, Brandes A, Cabanelas N, Dan GA, Dichtl W, Goette A, de Groot JR, Lubinski A, Marijon E, Merkely B, Mont L, Piorkowski C, Sarkozy A, Sulke N, Vardas P, Velchev V, Wichterle D, Kirchhof P. Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence. Europace. 2019 Oct 1;21(10):1459-1467. doi: 10.1093/europace/euz172.
28760205

Label	URL
NOAH Trial	View source

ID	Title	Description
FG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 1, 2020	Jan 30, 2024

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

Composite of Stroke, Systemic Embolism, or Cardiovascular Death

Time from randomisation to the first occurrence of stroke, systemic embolism, or cardiovascular death; incidence of first occurence of outcome measure.

The primary analysis is in the modified intention-to-treat population, consisting of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug.

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Units	Counts
Participants	OG0001270 OG0011264
patient-years	OG0002556 OG001

Title

Denominators

Categories

Title	Measurements
	OG0003.3 OG0014.0

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		Cause-spec. Cox Proport. Hazard model		0.15		adjusted cause-specific hazard ratio	0.81			2-Sided	95	0.6	1.08					Superiority

Secondary

Components of the Primary Outcome, Stroke

Time from randomisation to the first occurrence of ischemic stroke; incidence of first occurence of outcome measure.

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Major Adverse Cardiac Events (MACEs: Cardiac Death, Myocardial Infarction, Acute Coronary Syndrome (ACS)

PCI, CABG

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

All-cause Death

All-cause death

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Major Bleeding Events

according to the International Society on Thrombosis and Haemostasis (ISTH) definitions

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Quality of Life Changes at 12 and 24 Months Compared to Baseline

Adjusted mean change from baseline at 12 and 24 months of Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state), with 5.1% of the states valued as worse than dead. EQ5D- VAS: visual-analogue scale (0 worst to 100 best).

Subscales of the UK index score were combined by adding up EQ-5D-5L index values with STATA using the English (ENG) Devlin value set, Version 1.1 (Updated 01/12/2020).

Karnofsky Performance Scale is an 11-point scale from 0 to 100 (0 worst to 100 best).

Posted

Number

95% Confidence Interval

adjusted mean change from baseline

Baseline, 12 months and 24 months.

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001

Secondary

Patient Satisfaction at 12 and 24 Months Compared to Baseline

Adjusted change from baseline at 12 and 24 months measured by the Perception of Anticoagulant Treatment Questionnaire: For convenience score, a 0 - 100 scale; for satisfaction score a 0 - 100 scale; for both scores, the higher the score, the higher the convenience/satisfaction.

Posted

Number

95% Confidence Interval

scores on a scale (with 95% Confidence I

Baseline, 12 months and 24 months.

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Cost Effectiveness and Health Resource Utilisation

estimated by quantification of relevant events, interventions, nights spent in hospital and cardiovascular therapies

Not Posted

28 months

Participants

Secondary

Autonomy Status

Autonomy status only in patients with stroke during study participation, assessed at 24 month by modified Rankin scale. (Score ranges from 1 to 8, a higher score indicates a higher grade of disability)

MoCA Stroke Severity in patients with a stroke estimated by the Modified Rankin Scale at FU24.

Posted

Median

Inter-Quartile Range

Scores on a scale

Baseline and 24 months

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Components of the Primary Outcome, Systemic Embolism

Time from randomisation to the first occurrence of systemic embolism; incidence of first occurence of outcome measure.

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Secondary

Components of the Primary Outcome, Cardiovascular Death

Time from randomisation to the first occurrence of cardiovascular death; incidence of first occurence of outcome measure.

Posted

Number

number of new events per 100 pat.-years

28 months

patient-years

ID	Title	Description
OG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
OG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG00055 events44 affected1,306 at risk EG00126 events16 affected1,302 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Paratracheal lymphadenopathy	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0019 events9 affected1,302 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events14 affected1,306 at risk EG00121 events19 affected1,302 at risk
Angina pectoris	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00017 events14 affected1,306 at risk EG00111 events11 affected1,302 at risk
Angina unstable	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0015 events5 affected1,302 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00050 events38 affected1,306 at risk EG00151 events39 affected1,302 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG00111 events11 affected1,302 at risk
Atrial thrombosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bundle branch block left	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cardiac amyloidosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events1 affected1,302 at risk
Cardiac arrest	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG000145 events93 affected1,306 at risk EG001131 events90 affected1,302 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0016 events6 affected1,302 at risk
Coronary artery disease	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0018 events8 affected1,302 at risk
Dilated cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Extrasystoles	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0014 events3 affected1,302 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Myocardial infarction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0016 events6 affected1,302 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Palpitations	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pericardial effusion	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pericarditis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0015 events4 affected1,302 at risk
Haemophilia	Congenital, familial and genetic disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0015 events4 affected1,302 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Amaurosis fugax	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Eye haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retinal artery occlusion	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Retinal haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events3 affected1,302 at risk
Retinal vein occlusion	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Retinal vein thrombosis	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vision blurred	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Visual field defect	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vitreoretinal traction syndrome	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal incarcerated hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Colitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG0015 events5 affected1,302 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0016 events6 affected1,302 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Enteritis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Gastritis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00066 events50 affected1,306 at risk EG00123 events19 affected1,302 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal vascular malformation haemorrhagic	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0012 events2 affected1,302 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ileus	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0014 events3 affected1,302 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Melaena	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0014 events4 affected1,302 at risk
Mesenteric artery embolism	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Oesophageal mucosa erythema	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Proctitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Proctitis haemorrhagic	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Adverse drug reaction	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Asthenia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cardiac death	General disorders	MedDRA (19.1)	Systematic Assessment	EG00021 events21 affected1,306 at risk EG00122 events22 affected1,302 at risk
Chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0014 events4 affected1,302 at risk
Death	General disorders	MedDRA (19.1)	Systematic Assessment	EG000103 events103 affected1,306 at risk EG00188 events87 affected1,302 at risk
Gait disturbance	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
General physical health deterioration	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Impaired healing	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Multimorbidity	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0015 events5 affected1,302 at risk
Oedema	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Oedema peripheral	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Pacemaker generated arrhythmia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Peripheral swelling	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Puncture site haemorrhage	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0014 events4 affected1,302 at risk
Sudden cardiac death	General disorders	MedDRA (19.1)	Systematic Assessment	EG00018 events18 affected1,306 at risk EG00115 events15 affected1,302 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ulcer	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG0013 events3 affected1,302 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG0015 events5 affected1,302 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Jaundice	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypersensitivity	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Appendicitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Arthritis infective	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bacteraemia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Biliary sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Brain abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bronchitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bronchitis viral	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Clostridium colitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Coronavirus infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cystitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Device related infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Diverticulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0014 events4 affected1,302 at risk
Emphysematous pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Empyema	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Endocarditis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Enterococcal sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Erysipelas	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Fungal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastric ulcer helicobacter	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastroenteritis rotavirus	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Groin abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hepatic cyst infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hepatitis E	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Herpes zoster	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Implant site infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0018 events7 affected1,302 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Intervertebral discitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0015 events5 affected1,302 at risk
Mediastinal abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myelitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Osteomyelitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Otitis media chronic	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pancreatic abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Papilloma viral infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00074 events58 affected1,306 at risk EG00161 events56 affected1,302 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Post procedural infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Postoperative wound infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG0013 events3 affected1,302 at risk
Rhinovirus infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Sepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0019 events9 affected1,302 at risk
Septic shock	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG0015 events5 affected1,302 at risk
Streptococcal endocarditis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Superinfection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Superinfection bacterial	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00025 events23 affected1,306 at risk EG00121 events19 affected1,302 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0017 events7 affected1,302 at risk
Viral infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Wound infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Accident at home	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG00017 events16 affected1,306 at risk EG00123 events20 affected1,302 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG00110 events10 affected1,302 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Immunisation reaction	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0017 events7 affected1,302 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Osteoradionecrosis	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0017 events6 affected1,302 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Reactive gastropathy	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0012 events2 affected1,302 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Stoma complication	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Angiocardiogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG00022 events20 affected1,306 at risk EG00126 events26 affected1,302 at risk
Angiogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events4 affected1,302 at risk
Arteriogram carotid	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aspiration joint	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aspiration pleural cavity	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biopsy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biopsy adrenal gland	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy bladder	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biopsy heart	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy kidney	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy lung	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy lymph gland	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biopsy pericardium	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy prostate	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy skin	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Capsule endoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac electrophysiologic study	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cardiac pacemaker evaluation	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Catheterisation cardiac	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Colonoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG00045 events37 affected1,306 at risk EG00121 events20 affected1,302 at risk
Coronavirus test positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG00041 events34 affected1,306 at risk EG00137 events36 affected1,302 at risk
Cystoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Diagnostic procedure	Investigations	MedDRA (19.1)	Systematic Assessment	EG00048 events40 affected1,306 at risk EG00118 events16 affected1,302 at risk
Electrocardiogram ambulatory	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endoscopic retrograde cholangiopancreatography	Investigations	MedDRA (19.1)	Systematic Assessment	EG00017 events14 affected1,306 at risk EG0016 events6 affected1,302 at risk
Endoscopy small intestine	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endoscopy upper gastrointestinal tract	Investigations	MedDRA (19.1)	Systematic Assessment	EG00064 events54 affected1,306 at risk EG00127 events23 affected1,302 at risk
Human rhinovirus test positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mediastinoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Oesophageal manometry	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Paranasal biopsy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pneumovirus test positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sleep study	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ureteroscopy abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Venogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Viral test negative	Investigations	MedDRA (19.1)	Systematic Assessment	EG000130 events95 affected1,306 at risk EG001122 events93 affected1,302 at risk
Weight decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG0018 events7 affected1,302 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0013 events2 affected1,302 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Gout	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events4 affected1,302 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0014 events3 affected1,302 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events3 affected1,302 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events1 affected1,302 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0012 events2 affected1,302 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG00110 events10 affected1,302 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events4 affected1,302 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 events1 affected1,306 at risk EG0014 events2 affected1,302 at risk
Carcinoma in situ of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG00014 events10 affected1,306 at risk EG0012 events2 affected1,302 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0006 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0005 events2 affected1,306 at risk EG0012 events1 affected1,302 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG00011 events8 affected1,306 at risk EG0019 events6 affected1,302 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastases to pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastases to the mediastinum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0012 events2 affected1,302 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nasal sinus cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0007 events5 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0014 events1 affected1,302 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pleural mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG0014 events3 affected1,302 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Renal cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0013 events2 affected1,302 at risk
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events1 affected1,302 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0004 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Amnesia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cerebellar haemorrhage	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cerebral haematoma	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cognitive disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dementia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Disturbance in attention	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Embolic stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0019 events9 affected1,302 at risk
Epilepsy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events2 affected1,302 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00025 events25 affected1,306 at risk EG00130 events29 affected1,302 at risk
Lacunar stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Loss of consciousness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Memory impairment	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nervous system disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nystagmus	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Paraplegia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Parkinson's disease	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Parkinsonism	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Polyneuropathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Presyncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Sciatica	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Seizure	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Speech disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0014 events4 affected1,302 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events9 affected1,306 at risk EG0019 events9 affected1,302 at risk
Transient global amnesia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG0015 events5 affected1,302 at risk
Device dislocation	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Device inappropriate shock delivery	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Device lead issue	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Device malfunction	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Device occlusion	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lead dislodgement	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events4 affected1,302 at risk
Undersensing	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aggression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Agitation	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Chronic idiopathic pain syndrome	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Completed suicide	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Confusional state	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Delirium	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Disorientation	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Disturbance in social behaviour	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Drug abuse	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Drug dependence	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Insomnia	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mental disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Suicide attempt	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG00014 events14 affected1,306 at risk EG00114 events13 affected1,302 at risk
Bladder disorder	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0017 events6 affected1,302 at risk
Dysuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG00013 events9 affected1,306 at risk EG00110 events8 affected1,302 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nocturia	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Prerenal failure	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal failure	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0016 events5 affected1,302 at risk
Renal impairment	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal pelvis fistula	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Genital lesion	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events8 affected1,306 at risk EG00110 events8 affected1,302 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cystic lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events8 affected1,306 at risk EG0018 events8 affected1,302 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG00110 events8 affected1,302 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG00110 events10 affected1,302 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events11 affected1,306 at risk EG0017 events7 affected1,302 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Thoracic haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemorrhage subcutaneous	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Abdominal cavity drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Abdominal wall operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abscess drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Anal lesion excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aneurysm repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Angioplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0007 events5 affected1,306 at risk EG0015 events5 affected1,302 at risk
Aortic aneurysm repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic bypass	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aortic stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Appendicectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Arterial aneurysm repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arterial stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Arthrodesis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Atrial appendage closure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bile duct stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bile duct stent removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biliary catheter insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bladder catheter removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bladder catheter temporary	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bladder catheterisation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bladder polypectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Brachytherapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events1 affected1,302 at risk
Breast conserving surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Breast prosthesis removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bunion operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bursa removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cancer surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00016 events15 affected1,306 at risk EG00115 events15 affected1,302 at risk
Cardiac pacemaker adjustment	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0014 events4 affected1,302 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00039 events38 affected1,306 at risk EG00158 events57 affected1,302 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00020 events19 affected1,306 at risk EG00114 events13 affected1,302 at risk
Cardioversion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00029 events21 affected1,306 at risk EG00122 events21 affected1,302 at risk
Carotid endarterectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cataract operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Central venous catheter removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Central venous catheterisation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Chemotherapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00011 events11 affected1,306 at risk EG0016 events6 affected1,302 at risk
Cholelithotomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Circumcision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Colectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0009 events8 affected1,306 at risk EG0013 events3 affected1,302 at risk
Colostomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events2 affected1,302 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00032 events29 affected1,306 at risk EG00130 events27 affected1,302 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0014 events4 affected1,302 at risk
Corpora cavernosa surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Craniectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cyst drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cytoreductive surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Debridement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Duodenal sphincterotomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Duodenectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ear tube insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Electrocoagulation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endarterectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eventration repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eyelid operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Foot amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrointestinal endoscopic therapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrostomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Glossectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematoma evacuation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemodialysis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemorrhoid operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hernia repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
High frequency ablation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00017 events16 affected1,306 at risk EG00111 events11 affected1,302 at risk
Hip surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ileostomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Immunochemotherapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Infiltration anaesthesia	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Internal fixation of fracture	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00010 events9 affected1,306 at risk EG0019 events9 affected1,302 at risk
Intestinal operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Intra-aortic balloon placement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Jejunectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Joint fluid drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0016 events6 affected1,302 at risk
Knee operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0014 events4 affected1,302 at risk
Laparoscopic surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Laparotomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0011 events1 affected1,302 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Laryngeal operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Laryngeal prosthesis placement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Laryngectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lesion excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Limb amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lithotripsy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Liver ablation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Liver operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lung lobectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lymphadenectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Mammoplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Medical device implantation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Meningioma surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Neck dissection	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nephrectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nephrostomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Oesophageal dilation procedure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophageal prosthesis insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Orthopaedic procedure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pancreaticoduodenectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Paracentesis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Parathyroidectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Parotidectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pelvic operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00033 events28 affected1,306 at risk EG00139 events36 affected1,302 at risk
Pericardial drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Peripheral artery angioplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Peripheral artery bypass	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Peripheral artery stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Peripheral nerve destruction	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pharyngeal fistula repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pharyngeal operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pleurectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Polypectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Positive airway pressure therapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Proctectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0010 events0 affected1,302 at risk
Prostatectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ptosis repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Radiotherapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Radiotherapy to lung	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Radiotherapy to rectum	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rectal prolapse repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Removal of internal fixation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Renal stone removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Resuscitation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0015 events5 affected1,302 at risk
Shoulder operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Small intestinal resection	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Spinal decompression	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Spinal operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events4 affected1,302 at risk
Surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Therapeutic procedure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00022 events16 affected1,306 at risk EG0017 events6 affected1,302 at risk
Thoracic cavity drainage	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events2 affected1,302 at risk
Thrombectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0015 events5 affected1,302 at risk
Thrombolysis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0014 events4 affected1,302 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Toe amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tracheostomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Transcatheter aortic valve implantation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0015 events5 affected1,302 at risk
Transfusion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00078 events58 affected1,306 at risk EG00137 events28 affected1,302 at risk
Transurethral bladder resection	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00011 events9 affected1,306 at risk EG0015 events4 affected1,302 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0013 events2 affected1,302 at risk
Tumour excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Umbilical hernia repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ureteral stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ureteral stent removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Urethrotomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urinary cystectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urinary incontinence surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Uterine prolapse repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vaginal prolapse repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Varicose vein operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vascular operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0015 events4 affected1,302 at risk
Vitrectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vocal cord operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Angiodysplasia	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events5 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic aneurysm	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic stenosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bleeding varicose vein	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Circulatory collapse	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Embolism arterial	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Giant cell arteritis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haematoma	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Haemorrhage	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events18 affected1,306 at risk EG00110 events10 affected1,302 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Hypertensive emergency	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Lymphoedema	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0012 events2 affected1,302 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0018 events6 affected1,302 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Peripheral embolism	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Thrombophlebitis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vasculitis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Venous stenosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Venous thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG00013 events12 affected1,306 at risk EG0018 events8 affected1,302 at risk
Blood disorder	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Lymph node calcification	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Normochromic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Angina pectoris	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00013 events12 affected1,306 at risk EG00110 events8 affected1,302 at risk
Angina unstable	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events4 affected1,306 at risk EG00111 events11 affected1,302 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00010 events9 affected1,306 at risk EG0014 events4 affected1,302 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bradycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00029 events20 affected1,306 at risk EG00118 events18 affected1,302 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Coronary artery disease	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Palpitations	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events20 affected1,306 at risk EG0017 events7 affected1,302 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG0013 events3 affected1,302 at risk
Auricular swelling	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events8 affected1,306 at risk EG0018 events7 affected1,302 at risk
Graves' disease	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hypothyroidism	Endocrine disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Age-related macular degeneration	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Amaurosis fugax	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Blepharitis	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cataract	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events9 affected1,306 at risk EG0018 events7 affected1,302 at risk
Cataract nuclear	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Charles Bonnet syndrome	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Choroidal haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Conjunctival hyperaemia	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Conjunctival irritation	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dacryostenosis acquired	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dermatochalasis	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eye haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Eye inflammation	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eye pain	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Eyelid bleeding	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lacrimation increased	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Macular degeneration	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Maculopathy	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ocular hyperaemia	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Optic disc haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retinal detachment	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retinal haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retinal tear	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Retinal vein occlusion	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Uveitis	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vision blurred	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Visual acuity reduced	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Visual impairment	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Vitreous floaters	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG00119 events16 affected1,302 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00010 events10 affected1,306 at risk EG0013 events3 affected1,302 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Colitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Constipation	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0018 events8 affected1,302 at risk
Diaphragmatic hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events19 affected1,306 at risk EG00121 events20 affected1,302 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0013 events3 affected1,302 at risk
Flatulence	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastritis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0018 events8 affected1,302 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0012 events2 affected1,302 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0005 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lip haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Melaena	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nausea	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG00021 events21 affected1,306 at risk EG00111 events11 affected1,302 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Peritoneal cyst	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG0016 events5 affected1,302 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rectal tenesmus	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Toothache	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Trichoglossia	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vomiting	Gastrointestinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Adverse drug reaction	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Asthenia	General disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events18 affected1,306 at risk EG00117 events15 affected1,302 at risk
Chest discomfort	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG00021 events20 affected1,306 at risk EG00120 events19 affected1,302 at risk
Complication associated with device	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Facial pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Fatigue	General disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG00111 events11 affected1,302 at risk
Gait disturbance	General disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0014 events4 affected1,302 at risk
General physical health deterioration	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Illness	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Inflammation	General disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Infusion site extravasation	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Malaise	General disorders	MedDRA (19.1)	Systematic Assessment	EG00010 events10 affected1,306 at risk EG0014 events4 affected1,302 at risk
Non-cardiac chest pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG00013 events7 affected1,306 at risk EG0017 events7 affected1,302 at risk
Oedema	General disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0013 events3 affected1,302 at risk
Oedema peripheral	General disorders	MedDRA (19.1)	Systematic Assessment	EG00020 events16 affected1,306 at risk EG00119 events19 affected1,302 at risk
Pain	General disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Peripheral swelling	General disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0017 events7 affected1,302 at risk
Pyrexia	General disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0015 events5 affected1,302 at risk
Swelling face	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ulcer	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Vaccination site haematoma	General disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Congestive hepatopathy	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hepatic pain	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Primary biliary cholangitis	Hepatobiliary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hypersensitivity	Immune system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bacteriuria	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bronchitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0017 events7 affected1,302 at risk
Candida infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0012 events1 affected1,302 at risk
Chronic sinusitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Conjunctivitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0012 events2 affected1,302 at risk
Cystitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Dacryocystitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Diverticulitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ear infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ear infection fungal	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endocarditis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Erysipelas	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Eye infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Folliculitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Fungal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Fungal skin infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Herpes zoster	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Impetigo	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Implant site infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Infected dermal cyst	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Liver abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Localised infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0018 events6 affected1,302 at risk
Lyme disease	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG00111 events11 affected1,302 at risk
Orchitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pharyngitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0014 events4 affected1,302 at risk
Pulpitis dental	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0004 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pyelonephritis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG00111 events8 affected1,302 at risk
Rhinitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sinusitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tinea pedis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tooth abscess	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Tooth infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0015 events5 affected1,302 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG00033 events18 affected1,306 at risk EG00124 events19 affected1,302 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vestibular neuronitis	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Viral infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Wound infection	Infections and infestations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events2 affected1,302 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG0014 events4 affected1,302 at risk
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eyelid injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG00037 events32 affected1,306 at risk EG00135 events31 affected1,302 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0005 events4 affected1,306 at risk EG00113 events13 affected1,302 at risk
Heat exhaustion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0016 events6 affected1,302 at risk
Implantation complication	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0007 events5 affected1,306 at risk EG0018 events7 affected1,302 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events1 affected1,302 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Scar	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Shoulder fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Silicosis	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Angiocardiogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Angiogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Arthroscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Biopsy intestine	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Biopsy lymph gland	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Biopsy prostate	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bleeding time prolonged	Investigations	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Blood cholesterol increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Blood creatinine increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Blood magnesium decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Body temperature increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bronchial aspiration procedure	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bronchoscopy abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Catheterisation cardiac	Investigations	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Colonoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0012 events2 affected1,302 at risk
Coronavirus test positive	Investigations	MedDRA (19.1)	Systematic Assessment	EG00049 events48 affected1,306 at risk EG00130 events30 affected1,302 at risk
Cystoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dental examination	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Diagnostic procedure	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Echocardiogram	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Echocardiogram abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ejection fraction decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Endoscopy	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Endoscopy upper gastrointestinal tract	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Glomerular filtration rate increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haemoglobin decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haemoglobin increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Heart rate decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Heart rate increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hepatic enzyme increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
International normalised ratio abnormal	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Low density lipoprotein increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Magnetic resonance imaging	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Platelet count decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Prostatic specific antigen increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Radioisotope scan	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal ultrasound	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Serum ferritin decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Sleep study	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Spirometry	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Troponin increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vitamin D decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Weight decreased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0018 events7 affected1,302 at risk
Weight increased	Investigations	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0014 events4 affected1,302 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gout	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0014 events4 affected1,302 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00023 events18 affected1,306 at risk EG00127 events24 affected1,302 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events3 affected1,302 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events11 affected1,306 at risk EG00125 events19 affected1,302 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haematoma muscle	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Joint microhaemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0010 events0 affected1,302 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00010 events9 affected1,306 at risk EG0014 events3 affected1,302 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0009 events9 affected1,306 at risk EG00116 events15 affected1,302 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vertebral lesion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events2 affected1,302 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Carcinoma in situ of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Colorectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events1 affected1,302 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Myeloproliferative neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0007 events7 affected1,306 at risk EG0015 events5 affected1,302 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events2 affected1,302 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ataxia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Axonal neuropathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Balance disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cognitive disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Dementia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0016 events6 affected1,302 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00057 events47 affected1,306 at risk EG00152 events46 affected1,302 at risk
Dizziness postural	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Dysarthria	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Facial paralysis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Facial paresis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00021 events20 affected1,306 at risk EG00121 events19 affected1,302 at risk
Hemiparesis	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Lethargy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Loss of consciousness	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Memory impairment	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Neuralgia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ophthalmic migraine	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Paraesthesia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0012 events2 affected1,302 at risk
Parkinson's disease	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Polyneuropathy	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Presyncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Sciatica	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0015 events5 affected1,302 at risk
Seizure	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Somnolence	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Speech disorder	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG00016 events15 affected1,306 at risk EG00114 events11 affected1,302 at risk
Tremor	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Vascular dementia	Nervous system disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Device electrical impedance issue	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Device inappropriate shock delivery	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Device lead damage	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Device lead issue	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Device malfunction	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Device occlusion	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Device stimulation issue	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lead dislodgement	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Thrombosis in device	Product Issues	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Anxiety	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0014 events4 affected1,302 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Apathy	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Confusional state	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events3 affected1,302 at risk
Depressed mood	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Disorientation	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Insomnia	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0013 events3 affected1,302 at risk
Mental disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Panic attack	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Restlessness	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Sleep disorder	Psychiatric disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0010 events0 affected1,302 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bladder wall calcification	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events5 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dysuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haematuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG00041 events31 affected1,306 at risk EG00110 events8 affected1,302 at risk
Nocturia	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Oliguria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Polyuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Proteinuria	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal colic	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal failure	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Renal impairment	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Renal pain	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Breast mass	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events1 affected1,302 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0014 events4 affected1,302 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00010 events9 affected1,306 at risk EG0018 events8 affected1,302 at risk
Diaphragmatic spasm	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00046 events43 affected1,306 at risk EG00150 events42 affected1,302 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events10 affected1,306 at risk EG0016 events6 affected1,302 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG00054 events48 affected1,306 at risk EG00122 events21 affected1,302 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Nocturnal dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Orthopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Chronic papillomatous dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0010 events0 affected1,302 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00013 events13 affected1,306 at risk EG0018 events8 affected1,302 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Purpura	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG00011 events10 affected1,306 at risk EG00112 events9 affected1,302 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0012 events2 affected1,302 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Xeroderma	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Breast prosthesis user	Social circumstances	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Living in residential institution	Social circumstances	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arthrodesis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Bladder neoplasm surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Blepharoplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Bunion operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cancer surgery	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac pacemaker removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00036 events36 affected1,306 at risk EG00140 events39 affected1,302 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0006 events6 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cardioversion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0007 events6 affected1,306 at risk EG00111 events9 affected1,302 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0013 events3 affected1,302 at risk
Cataract operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00015 events11 affected1,306 at risk EG00115 events12 affected1,302 at risk
Catheter management	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events2 affected1,302 at risk
Cholelithotomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Dental implantation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Electrocauterisation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Endodontic procedure	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eye operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Eyelid operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0004 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Finger amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Gastric polypectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Haematoma evacuation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hernia repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hydrocele operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Internal fixation of fracture	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Jaw operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Knee operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0013 events2 affected1,302 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0005 events5 affected1,306 at risk EG0010 events0 affected1,302 at risk
Liver operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Medical device removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Mole excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Papilloma excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Peripheral artery angioplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Prostatic operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Radiotherapy to prostate	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Rhinoplasty	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Rhizolysis	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Sclerotherapy	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Shoulder operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin lesion removal	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00010 events8 affected1,306 at risk EG0016 events5 affected1,302 at risk
Skin operation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Toe amputation	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Tooth extraction	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG00012 events11 affected1,306 at risk EG0014 events4 affected1,302 at risk
Transurethral bladder resection	Surgical and medical procedures	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Angiodysplasia	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic aneurysm	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events3 affected1,306 at risk EG0012 events2 affected1,302 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aortic dilatation	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Aortic stenosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Aortic thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Arteriosclerosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Bleeding varicose vein	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Circulatory collapse	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0011 events1 affected1,302 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Haematoma	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG00024 events21 affected1,306 at risk EG00117 events17 affected1,302 at risk
Haemorrhage	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0006 events4 affected1,306 at risk EG0012 events2 affected1,302 at risk
Hot flush	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0008 events8 affected1,306 at risk EG00111 events10 affected1,302 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0014 events4 affected1,302 at risk
Hypertensive emergency	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0013 events3 affected1,302 at risk
Hypertensive urgency	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG00014 events13 affected1,306 at risk EG00112 events11 affected1,302 at risk
Intermittent claudication	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0004 events4 affected1,306 at risk EG0011 events1 affected1,302 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0002 events2 affected1,306 at risk EG0012 events2 affected1,302 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Peripheral venous disease	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0003 events2 affected1,306 at risk EG0010 events0 affected1,302 at risk
Phlebitis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Subgaleal haematoma	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Superficial vein thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0012 events2 affected1,302 at risk
Thrombophlebitis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0012 events2 affected1,302 at risk
Thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0000 events0 affected1,306 at risk EG0011 events1 affected1,302 at risk
Varicose ulceration	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk
Varicose vein	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0010 events0 affected1,302 at risk
Venous thrombosis	Vascular disorders	MedDRA (19.1)	Systematic Assessment	EG0001 events1 affected1,306 at risk EG0011 events1 affected1,302 at risk

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

ID	Title	Description
BG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.
BG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Edoxaban	Edoxaban will be applied in NOAH at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole. Edoxaban: Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein-P inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.	142	1,306	498	1,306	718	1,306
EG001	ASA or Placebo	Either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator ASA: ASA 100 mg tablets or Placebo, based on accepted indication for the latter, including peripherial or coronary artery disease, a prior myocardial infarction, or a prior stroke.	125	1,302	467	1,302	662	1,302