A Study to Evaluate the Effect of Dapagliflozin on Renal... | NCT03036150

NCT03036150

ID	Type	Description	Link
2016-003896-24	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dapagliflozin	Experimental	Patients will be randomized 1:1 to either dapagliflozin or placebo.	Drug: Dapagliflozin
Placebo	Placebo Comparator	Placebo matching dapagliflozin.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dapagliflozin	Drug	10 mg or 5 mg tablets given once daily, per oral use.	Dapagliflozin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.	End Stage Renal Disease (ESRD) is defined as: Sustained eGFR <15 mL/min/1.73m2 or, Chronic dialysis treatment or, Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.	Up to 38.2 months

Secondary Outcomes

Measure	Description	Time Frame
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.	End Stage Renal Disease (ESRD) is defined as: Sustained eGFR <15 mL/min/1.73m2 or, Chronic dialysis treatment or, Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35233	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41926219	Derived	Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.
41128261

Label	URL
redacted protocol	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
FG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 17, 2020	Apr 19, 2021

Arm/Group Information

ID	Title	Description
BG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
BG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00061.8± 12.1 BG00161.9± 12.1 BG00261.8± 12.1

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<= 50 years	BG000362 BG001370 BG002

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<= 65 years	BG0001247 BG0011239 BG002

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=65 years	BG0001247 BG0011239 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000709 BG001716 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000522 BG001550 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG0001124 BG0011166 BG002

Most likely etiology of CKD

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Diabetic Nephropathy	BG0001271 BG0011239 BG002

eGFR

Mean

Standard Deviation

mL/min/1.73 m2

Title

Denominators

Categories

Title	Measurements
	BG00043.2± 12.3 BG00143.0± 12.4 BG002

Urine albumin creatinine ratio

Median

Inter-Quartile Range

mg/g

Title

Denominators

Categories

Title	Measurements
	BG000965(472 to 1903) BG001934(482 to 1869) BG002

Type 2 Diabetes Mellitus at Baseline

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG0001455 BG0011451 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.

End Stage Renal Disease (ESRD) is defined as:

Sustained eGFR <15 mL/min/1.73m2 or,
Chronic dialysis treatment or,
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

Posted

Count of Participants

Participants

Up to 38.2 months

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
OG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Units	Counts
Participants	OG0002152 OG0012152

Title

Denominators

Categories

Title	Measurements
	OG000197 OG001312

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		Regression, Cox	Stratified by randomization stratification of Type 2 Diabetes and urine albumin creatinine ratio and adjusting for baseline eGFR.	< 0.0001		Hazard Ratio (HR)	0.61				95	0.51	0.72					Superiority

Secondary

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.

End Stage Renal Disease (ESRD) is defined as:

Sustained eGFR <15 mL/min/1.73m2 or,
Chronic dialysis treatment or,
Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

For the secondary endpoints the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

Posted

Count of Participants

Participants

Up to 38.2 months

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
OG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Units	Counts
Participants

Secondary

Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.

The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

Posted

Count of Participants

Participants

Up to 38.2 months

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
OG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Units	Counts
Participants	OG000

Secondary

Time to Death From Any Cause.

Posted

Count of Participants

Participants

Up to 38.2 months

ID	Title	Description
OG000	Dapagliflozin	Dapagliflozin 10 mg, given once daily per oral use
OG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dapa 10 mg	Dapagliflozin 10 mg, given once daily per oral use	107	2,152	633	2,149	479	2,149
EG001	Placebo	Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use	159	2,152	729	2,149	500	2,149

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected2,149 at risk EG0018 events8 affected2,149 at risk
Blood loss anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0013 events2 affected2,149 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0016 events6 affected2,149 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG00112 events10 affected2,149 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00035 events32 affected2,149 at risk EG00156 events46 affected2,149 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected2,149 at risk EG0019 events9 affected2,149 at risk
Angina unstable	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00017 events14 affected2,149 at risk EG00126 events22 affected2,149 at risk
Aortic valve disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected2,149 at risk EG00118 events17 affected2,149 at risk
Atrial flutter	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Atrioventricular block	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0015 events5 affected2,149 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0013 events3 affected2,149 at risk
Bundle branch block left	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cardiac arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG00110 events10 affected2,149 at risk
Cardiac failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00056 events39 affected2,149 at risk EG00172 events59 affected2,149 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected2,149 at risk EG0018 events7 affected2,149 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected2,149 at risk EG0015 events5 affected2,149 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00017 events13 affected2,149 at risk EG00129 events22 affected2,149 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0014 events3 affected2,149 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG00110 events10 affected2,149 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Defect conduction intraventricular	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0015 events3 affected2,149 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0014 events4 affected2,149 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Left ventricular failure	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected2,149 at risk EG0017 events6 affected2,149 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG0017 events6 affected2,149 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pericarditis	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Prinzmetal angina	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 23.0	Systematic Assessment	EG0007 events5 affected2,149 at risk EG0013 events3 affected2,149 at risk
Goitre	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hyperadrenocorticism	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pituitary-dependent cushing's syndrome	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cataract	Eye disorders	MedDRA 23.0	Systematic Assessment	EG00012 events8 affected2,149 at risk EG0018 events6 affected2,149 at risk
Cataract subcapsular	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diabetic retinal oedema	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diabetic retinopathy	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diplopia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Glaucoma	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ocular hyperaemia	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ocular ischaemic syndrome	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Retinal detachment	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Retinal haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vitreous disorder	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Colitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0012 events2 affected2,149 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events3 affected2,149 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastritis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0016 events5 affected2,149 at risk
Gastritis hypertrophic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0017 events6 affected2,149 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Haemoperitoneum	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Ileus	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Mesenteric vascular insufficiency	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Palatal disorder	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0006 events5 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events4 affected2,149 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Asthenia	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events2 affected2,149 at risk
Cardiac death	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Catheter site haemorrhage	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Death	General disorders	MedDRA 23.0	Systematic Assessment	EG00015 events15 affected2,149 at risk EG00127 events27 affected2,149 at risk
Fatigue	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Gait disturbance	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Generalised oedema	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Impaired healing	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Inflammation	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Medical device site discomfort	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Medical device site pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0015 events5 affected2,149 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pyrexia	General disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0014 events4 affected2,149 at risk
Stent-graft endoleak	General disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Sudden cardiac death	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Sudden death	General disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0011 events1 affected2,149 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0014 events4 affected2,149 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0015 events5 affected2,149 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Liver injury	Hepatobiliary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Sarcoidosis	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Transplant rejection	Immune system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Abscess limb	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Acquired immunodeficiency syndrome	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Acute hepatitis b	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Anal abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Appendicitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0013 events3 affected2,149 at risk
Appendicitis perforated	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Arthritis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Arthritis infective	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bacterial sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Biliary sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bronchitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0017 events6 affected2,149 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bronchitis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Covid-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Covid-19 pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Candida infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00017 events14 affected2,149 at risk EG00120 events15 affected2,149 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cholecystitis infective	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events4 affected2,149 at risk EG0011 events1 affected2,149 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Coronavirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cystitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Dengue fever	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Device related infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Device related sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diabetic foot infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0008 events5 affected2,149 at risk EG0016 events5 affected2,149 at risk
Diabetic gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Diverticulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0015 events5 affected2,149 at risk
Empyema	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Encephalitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Endocarditis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Erysipelas	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0016 events5 affected2,149 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Escherichia sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Fournier's gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Fungaemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Fungal oesophagitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Furuncle	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected2,149 at risk EG0014 events3 affected2,149 at risk
Gas gangrene	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00011 events10 affected2,149 at risk EG0019 events9 affected2,149 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0014 events4 affected2,149 at risk
Herpes zoster	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Infected skin ulcer	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected2,149 at risk EG0013 events2 affected2,149 at risk
Infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Influenza	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0013 events3 affected2,149 at risk
Inguinal hernia gangrenous	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Intestinal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Large intestine infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Leishmaniasis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Liver abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Localised infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0018 events8 affected2,149 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Mastoiditis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Mediastinitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Meningitis bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Osteomyelitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00012 events10 affected2,149 at risk EG00113 events12 affected2,149 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Otitis externa	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Otitis media	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Peritonitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pilonidal cyst	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Plasmodium falciparum infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pneumonia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00050 events44 affected2,149 at risk EG00179 events70 affected2,149 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pneumonia fungal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pneumonia legionella	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Post procedural infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Postoperative wound infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pyelonephritis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pyonephrosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Rocky mountain spotted fever	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00013 events13 affected2,149 at risk EG00118 events18 affected2,149 at risk
Septic shock	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected2,149 at risk EG00111 events11 affected2,149 at risk
Skin infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Soft tissue infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Splenic abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Streptococcal endocarditis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Superinfection viral	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Suspected covid-19	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tonsillitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tooth abscess	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tuberculosis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tuberculosis bladder	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG00022 events20 affected2,149 at risk EG00121 events15 affected2,149 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Urogenital infection bacterial	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Urosepsis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0013 events3 affected2,149 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Vulval cellulitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Wound infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0012 events2 affected2,149 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected2,149 at risk EG0015 events4 affected2,149 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lenticular injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Post procedural fever	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0012 events2 affected2,149 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Scapula fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0012 events1 affected2,149 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Vascular access malfunction	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Blood creatinine increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Blood glucose increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Blood parathyroid hormone increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Blood pressure increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Fibrin d dimer increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Hepatic enzyme increased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Oxygen saturation decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0019 events7 affected2,149 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00011 events9 affected2,149 at risk EG0016 events5 affected2,149 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0014 events4 affected2,149 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events3 affected2,149 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0014 events4 affected2,149 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0014 events4 affected2,149 at risk
Gout	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected2,149 at risk EG00119 events17 affected2,149 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Hyperinsulinaemic hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG00112 events12 affected2,149 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0009 events9 affected2,149 at risk EG00119 events18 affected2,149 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0012 events2 affected2,149 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Milk-alkali syndrome	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Shock hypoglycaemic	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected2,149 at risk EG0016 events6 affected2,149 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0014 events3 affected2,149 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0012 events2 affected2,149 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Benign biliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Bone giant cell tumour malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Craniopharyngioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diffuse large b-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Endometrial cancer stage i	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Epithelioid mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0016 events6 affected2,149 at risk
Lymphoplasmacytoid lymphoma/immunocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Metastases to bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Peripheral t-cell lymphoma unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG00010 events10 affected2,149 at risk EG0016 events6 affected2,149 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Prostate cancer stage ii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Renal cell carcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Renal hamartoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Soft tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Testicular germ cell cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vocal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Basal ganglia haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Brain hypoxia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Brain injury	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Brain oedema	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Brain stem infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Brain stem stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG0012 events2 affected2,149 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Cerebral infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected2,149 at risk EG0014 events3 affected2,149 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Cerebral vasoconstriction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00010 events10 affected2,149 at risk EG0018 events8 affected2,149 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Dementia	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Dysarthria	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Embolic stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Epilepsy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events4 affected2,149 at risk
Facial nerve disorder	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Facial paralysis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Guillain-barre syndrome	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hemiparesis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00023 events22 affected2,149 at risk EG00129 events28 affected2,149 at risk
Lacunar stroke	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Lumbosacral radiculopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Motor neurone disease	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Multiple sclerosis	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Partial seizures	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Presyncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Putamen haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Radiculopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Seizure	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Syncope	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0007 events7 affected2,149 at risk EG0015 events5 affected2,149 at risk
Tension headache	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Thalamic infarction	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG00011 events11 affected2,149 at risk EG00110 events9 affected2,149 at risk
Vascular encephalopathy	Nervous system disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Premature separation of placenta	Pregnancy, puerperium and perinatal conditions	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Device dislocation	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Device malfunction	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Device power source issue	Product Issues	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Completed suicide	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Confusional state	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Delirium	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0014 events4 affected2,149 at risk
Depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Post stroke depression	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Sleep disorder	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Suicide attempt	Psychiatric disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00043 events39 affected2,149 at risk EG00164 events52 affected2,149 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00024 events20 affected2,149 at risk EG00134 events31 affected2,149 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00027 events26 affected2,149 at risk EG00139 events36 affected2,149 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0003 events2 affected2,149 at risk EG0019 events6 affected2,149 at risk
Glomerulonephritis rapidly progressive	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0016 events2 affected2,149 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0004 events3 affected2,149 at risk EG0012 events2 affected2,149 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Iga nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Intercapillary glomerulosclerosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events4 affected2,149 at risk
Nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0013 events3 affected2,149 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events4 affected2,149 at risk
Nephrosclerosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0015 events3 affected2,149 at risk
Obstructive nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Prerenal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events3 affected2,149 at risk
Renal amyloidosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Renal colic	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Renal failure	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG00111 events10 affected2,149 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00015 events14 affected2,149 at risk EG00115 events15 affected2,149 at risk
Renal mass	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Urate nephropathy	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0013 events1 affected2,149 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Urethral dilatation	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0014 events4 affected2,149 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Vesical fistula	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG0014 events4 affected2,149 at risk
Endometrial disorder	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Seminal vesicular cyst	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events1 affected2,149 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0014 events4 affected2,149 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG00014 events12 affected2,149 at risk EG00112 events11 affected2,149 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0013 events3 affected2,149 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events7 affected2,149 at risk EG00113 events10 affected2,149 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0016 events4 affected2,149 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0012 events2 affected2,149 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected2,149 at risk EG0017 events7 affected2,149 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0005 events5 affected2,149 at risk EG0018 events8 affected2,149 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0016 events6 affected2,149 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0013 events1 affected2,149 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG00110 events7 affected2,149 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0017 events7 affected2,149 at risk
Aortic aneurysm	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0012 events2 affected2,149 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Aortic dissection	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Aortic stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0012 events2 affected2,149 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Arteriosclerosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG0016 events6 affected2,149 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Dry gangrene	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Extremity necrosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0010 events0 affected2,149 at risk
Femoral artery embolism	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Haematoma	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00013 events9 affected2,149 at risk EG00110 events10 affected2,149 at risk
Hypertensive crisis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0006 events6 affected2,149 at risk EG0015 events5 affected2,149 at risk
Hypertensive emergency	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0017 events6 affected2,149 at risk
Hypertensive urgency	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events2 affected2,149 at risk EG0011 events1 affected2,149 at risk
Hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0008 events8 affected2,149 at risk EG0013 events3 affected2,149 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Iliac artery embolism	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0008 events6 affected2,149 at risk EG0017 events7 affected2,149 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0000 events0 affected2,149 at risk EG0011 events1 affected2,149 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0003 events3 affected2,149 at risk EG0011 events1 affected2,149 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0002 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0004 events4 affected2,149 at risk EG0018 events8 affected2,149 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0011 events1 affected2,149 at risk
Thrombophlebitis	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG0001 events1 affected2,149 at risk EG0010 events0 affected2,149 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Systematic Assessment	EG00056 events45 affected2,149 at risk EG00146 events41 affected2,149 at risk
Oedema peripheral	General disorders	MedDRA 23.0	Systematic Assessment	EG00056 events54 affected2,149 at risk EG00175 events63 affected2,149 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG000136 events92 affected2,149 at risk EG001118 events81 affected2,149 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.0	Systematic Assessment	EG000102 events78 affected2,149 at risk EG00196 events79 affected2,149 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 23.0	Systematic Assessment	EG00045 events39 affected2,149 at risk EG00167 events61 affected2,149 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG00067 events53 affected2,149 at risk EG00154 events49 affected2,149 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Systematic Assessment	EG000119 events74 affected2,149 at risk EG00196 events70 affected2,149 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Systematic Assessment	EG00046 events44 affected2,149 at risk EG00152 events50 affected2,149 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00054 events49 affected2,149 at risk EG00150 events44 affected2,149 at risk
Renal impairment	Renal and urinary disorders	MedDRA 23.0	Systematic Assessment	EG00055 events51 affected2,149 at risk EG00172 events64 affected2,149 at risk
Hypertension	Vascular disorders	MedDRA 23.0	Systematic Assessment	EG00063 events62 affected2,149 at risk EG00166 events60 affected2,149 at risk

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms