A Study to Assess All-Cause Mortality and Cardiovascular... | NCT00773513

ID	Type	Description	Link
2007-005129-31

Label	Type	Description	Intervention Names
Erythropoiesis Stimulating Agents	Active Comparator	Participants will receive reference ESA according to approved label. The approved reference ESA compounds in the study will be darbepoetin alfa, epoetin alfa and epoetin beta.	Drug: Darbepoetin Alfa Drug: Epoetin Alfa Drug: Epoetin Beta Drug: methoxy polyethylene glycol-epoetin beta
Methoxy Polyethylene Glycol-Epoetin Beta	Experimental	Participants not currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta iv or sc once every 2 weeks for correction of renal anemia (target Hb 10-12 g/dL). Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta will be administered once monthly.	Drug: Darbepoetin Alfa Drug: Epoetin Alfa Drug: methoxy polyethylene glycol-epoetin beta

Name	Type	Description	Arm Group Labels	Other Names
Darbepoetin Alfa	Drug	Darbepoetin alfa will be administered as per approved label.	Erythropoiesis Stimulating Agents Methoxy Polyethylene Glycol-Epoetin Beta

Measure	Description	Time Frame
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First		Baseline up to approximately 8.5 years

Measure	Description	Time Frame
Time to All-Cause Mortality		Baseline up to approximately 8.5 years
Time to Non-Fatal and Fatal Myocardial Infarction		Baseline up to approximately 8.5 years

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fresenius Medical Care Martinez		Buenos Aires		1640	Argentina
Fresenius Medical Care Morón

PubMed Identifier	Type	Citation	Retractions
36791280	Derived	Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
31420350	Derived	Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.

ID	Title	Description
FG000	Erythropoiesis Stimulating Agents (ESA)	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
FG001	Methoxy Polyethylene Glycol-Epoetin Beta

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 23, 2015

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 Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First

The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.

Posted

Median

95% Confidence Interval

years

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Units	Counts
Participants	OG0001409 OG0011409

Title

Denominators

Categories

Title	Measurements
	OG0005.1(4.8 to 5.6) OG0015.1(4.7 to 5.4)

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		0.0039		Hazard Ratio (HR)	1.03			2-Sided	95	0.93	1.15			The pre-specified upper non-inferiority limit was 95% CI <1.20.		Non-Inferiority	The critical alpha level for the non-inferiority test was 0.025.

Secondary

Time to All-Cause Mortality

Posted

Median

95% Confidence Interval

years

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Time to Non-Fatal and Fatal Myocardial Infarction

Posted

Median

95% Confidence Interval

years

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Time to Non-Fatal and Fatal Stroke

Posted

Median

95% Confidence Interval

years

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)

Posted

Median

95% Confidence Interval

years

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)

Posted

Number

percentage of participants

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Percentage of Participants With Gastrointestinal Bleeding

Posted

Number

percentage of participants

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Secondary

Percentage of Participants With Thromboembolic Events

Posted

Number

percentage of participants

Baseline up to approximately 8.5 years

ID	Title	Description
OG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
OG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000163 affected1,409 at risk EG001180 affected1,409 at risk
Sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00085 affected1,409 at risk EG00169 affected1,409 at risk
Peritonitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00046 affected1,409 at risk EG00147 affected1,409 at risk
Septic shock	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00049 affected1,409 at risk EG00136 affected1,409 at risk
Gastroenteritis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00027 affected1,409 at risk EG00139 affected1,409 at risk
Urinary tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00033 affected1,409 at risk EG00131 affected1,409 at risk
Device related sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00030 affected1,409 at risk EG00121 affected1,409 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00028 affected1,409 at risk EG00121 affected1,409 at risk
Cellulitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00025 affected1,409 at risk EG00122 affected1,409 at risk
Device related infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00028 affected1,409 at risk EG00119 affected1,409 at risk
Bronchitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00024 affected1,409 at risk EG00120 affected1,409 at risk
Gangrene	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00020 affected1,409 at risk EG00122 affected1,409 at risk
Respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00023 affected1,409 at risk EG00116 affected1,409 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00018 affected1,409 at risk EG00114 affected1,409 at risk
Urosepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG00119 affected1,409 at risk
Bacteraemia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00014 affected1,409 at risk EG00110 affected1,409 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00014 affected1,409 at risk EG0019 affected1,409 at risk
Infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG00115 affected1,409 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG00110 affected1,409 at risk
Diabetic foot infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG00110 affected1,409 at risk
Diverticulitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG0015 affected1,409 at risk
Erysipelas	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00110 affected1,409 at risk
Endocarditis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG0017 affected1,409 at risk
Catheter site infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG0014 affected1,409 at risk
Postoperative wound infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG0014 affected1,409 at risk
Pyelonephritis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0015 affected1,409 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0013 affected1,409 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0014 affected1,409 at risk
Arthritis bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0013 affected1,409 at risk
Infected skin ulcer	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0013 affected1,409 at risk
Lung infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0013 affected1,409 at risk
Viral infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0018 affected1,409 at risk
Pyelonephritis acute	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0015 affected1,409 at risk
Wound infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0016 affected1,409 at risk
Escherichia sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Localised infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Pneumonia bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Pulmonary sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0012 affected1,409 at risk
Staphylococcal infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0018 affected1,409 at risk
Influenza	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0013 affected1,409 at risk
Osteomyelitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Peritonitis bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Herpes zoster	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Necrotising fasciitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Renal cyst infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Appendicitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Bacterial sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Cystitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Diabetic gangrene	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0015 affected1,409 at risk
Enterococcal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Abdominal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Abscess limb	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Anal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Infectious colitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Infectious pleural effusion	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0014 affected1,409 at risk
Soft tissue infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Biliary sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Fungal peritonitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
Gastroenteritis viral	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Graft infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
H1N1 influenza	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Acute sinusitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Cellulitis gangrenous	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Cholangitis infective	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Cholecystitis infective	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Intervertebral discitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Post procedural infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Post procedural sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Pyonephrosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Septic necrosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Sialoadenitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Streptococcal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Subcutaneous abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Tonsillitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Wound sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Abdominal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Appendicitis perforated	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Atypical pneumonia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Bacterial infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Clostridium difficile infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Diarrhoea infectious	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Empyema	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Encephalitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Endocarditis bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Enterobacter sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Epididymitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Epiglottitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Fungal oesophagitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Groin abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Haematoma infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Haemophilus infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Joint tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Klebsiella sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Listeriosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Lymph node tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Otitis media	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Proteus infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Renal graft infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Sinusitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Skin bacterial infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Systemic candida	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Abdominal wall abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Abdominal wall infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Abscess jaw	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Appendiceal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bacterial colitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bone abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bone tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bronchitis viral	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cat scratch disease	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Catheter site abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Chronic tonsillitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Citrobacter sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Colon gangrene	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Colonic abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Corneal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Corynebacterium sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cystitis bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dacryocystitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Endophthalmitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Enteritis infectious	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Escherichia infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Febrile infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gastrointestinal infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Genitourinary tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hepatic cyst infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Herpes sepsis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Herpes zoster meningoencephalitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Implant site infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Infected bunion	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Infected dermal cyst	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Infected fistula	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Infective gastroduodenitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Injection site infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Intestinal fistula infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Joint abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Klebsiella infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Listeria encephalitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Liver abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lung abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mesenteric abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Muscle abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mycetoma mycotic	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Nail infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nasopharyngitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Nosocomial infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Osteomyelitis acute	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Otitis externa	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Otitis media acute	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Parotitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pelvic abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Perihepatic abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Periodontal destruction	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Periodontitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Peritonsillar abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pharyngitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pneumonia legionella	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pneumonia necrotising	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Postoperative abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pyomyositis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Renal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Rotavirus infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Salmonellosis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Salpingitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Seminal vesicle abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Skin infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Staphylococcal abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Subacute endocarditis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Tooth abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Urethral abscess	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Vaginal infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Varicella	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00074 affected1,409 at risk EG00163 affected1,409 at risk
Atrial fibrillation	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00057 affected1,409 at risk EG00149 affected1,409 at risk
Myocardial infarction	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00050 affected1,409 at risk EG00154 affected1,409 at risk
Cardiac arrest	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00044 affected1,409 at risk EG00155 affected1,409 at risk
Angina pectoris	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00037 affected1,409 at risk EG00135 affected1,409 at risk
Cardiac failure	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00034 affected1,409 at risk EG00125 affected1,409 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00025 affected1,409 at risk EG00129 affected1,409 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00024 affected1,409 at risk EG00120 affected1,409 at risk
Coronary artery disease	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00024 affected1,409 at risk EG00120 affected1,409 at risk
Angina unstable	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00016 affected1,409 at risk EG00124 affected1,409 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00021 affected1,409 at risk EG00117 affected1,409 at risk
Bradycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00020 affected1,409 at risk EG0018 affected1,409 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG00012 affected1,409 at risk EG00110 affected1,409 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0018 affected1,409 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0019 affected1,409 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0019 affected1,409 at risk
Cardiogenic shock	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0015 affected1,409 at risk
Atrial flutter	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0014 affected1,409 at risk
Cardiac failure acute	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0019 affected1,409 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0018 affected1,409 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0017 affected1,409 at risk
Arrhythmia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0012 affected1,409 at risk
Left ventricular failure	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0012 affected1,409 at risk
Atrioventricular block	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Cardiomyopathy	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Aortic valve disease	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Atrial tachycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0010 affected1,409 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Pericardial effusion	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Pericarditis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Sinus bradycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Atrial thrombosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Right ventricular failure	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Aortic valve disease mixed	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Cardiac disorder	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Pericarditis uraemic	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Sinus tachycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Adams-Stokes syndrome	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bundle branch block left	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cardiac dysfunction	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cardiac tamponade	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Chordae tendinae rupture	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Conduction disorder	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Coronary artery dissection	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic cardiomyopathy	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dressler's syndrome	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Extrasystoles	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Heart valve incompetence	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Heart valve stenosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Myocarditis	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Palpitations	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Paroxysmal atrioventricular block	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Sinoatrial block	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Tachycardia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Torsade de pointes	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ventricular dyssynchrony	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG000110 affected1,409 at risk EG00177 affected1,409 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00057 affected1,409 at risk EG00147 affected1,409 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00023 affected1,409 at risk EG00126 affected1,409 at risk
Arteriovenous fistula site haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00016 affected1,409 at risk EG00123 affected1,409 at risk
Arteriovenous graft thrombosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG00123 affected1,409 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00019 affected1,409 at risk EG00114 affected1,409 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG00116 affected1,409 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00015 affected1,409 at risk EG0016 affected1,409 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00112 affected1,409 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00111 affected1,409 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG0017 affected1,409 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0019 affected1,409 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0015 affected1,409 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0017 affected1,409 at risk
Fall	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0015 affected1,409 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0018 affected1,409 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0015 affected1,409 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0013 affected1,409 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0017 affected1,409 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0012 affected1,409 at risk
Arteriovenous graft site stenosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0014 affected1,409 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0016 affected1,409 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0015 affected1,409 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Arterial bypass thrombosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Arteriovenous graft site haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0014 affected1,409 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Peritoneal dialysis complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Arteriovenous graft site haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Shunt aneurysm	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Device deployment issue	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Eschar	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Extensive interdialytic weight gain	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Haemodialysis complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hyphaema	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Kidney rupture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Postoperative delirium	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Procedural dizziness	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Radiation proctitis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Stoma site haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Traumatic coma	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vascular bypass dysfunction	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vasoplegia syndrome	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Wound	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00023 affected1,409 at risk EG00124 affected1,409 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00016 affected1,409 at risk EG00113 affected1,409 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG00118 affected1,409 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG0019 affected1,409 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00110 affected1,409 at risk
Gastritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG0015 affected1,409 at risk
Constipation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0017 affected1,409 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG00110 affected1,409 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0017 affected1,409 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0016 affected1,409 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0015 affected1,409 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0015 affected1,409 at risk
Melaena	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0017 affected1,409 at risk
Colitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0015 affected1,409 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0013 affected1,409 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0016 affected1,409 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0014 affected1,409 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0013 affected1,409 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0016 affected1,409 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0013 affected1,409 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0017 affected1,409 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0011 affected1,409 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Diverticulum	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0012 affected1,409 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0015 affected1,409 at risk
Enteritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0012 affected1,409 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Vomiting	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Gastrointestinal angiodysplasia haemorrhagic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Haematemesis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Haematochezia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Subileus	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Anal fistula	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Encapsulating peritoneal sclerosis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Gastrointestinal angiectasia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Haemorrhagic erosive gastritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Ileus	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Necrotising colitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Ascites	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Colitis erosive	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Dental caries	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Food poisoning	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Peritoneal perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Abdominal wall haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Anal fissure	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Anal ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Anorectal varices	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Appendiceal mucocoele	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic gastropathy	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Diverticulum oesophageal	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Duodenitis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Faecaloma	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Flatulence	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gallstone ileus	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gastroduodenal ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Gastrointestinal hypomotility	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Intestinal angina	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Intestinal varices	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ischaemic enteritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Large intestinal stenosis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nausea	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Oesophagitis haemorrhagic	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oral disorder	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Rectal ulcer haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Salivary gland enlargement	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Volvulus	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Peripheral ischaemia	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00031 affected1,409 at risk EG00131 affected1,409 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00024 affected1,409 at risk EG00124 affected1,409 at risk
Hypertension	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00024 affected1,409 at risk EG00123 affected1,409 at risk
Hypotension	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00018 affected1,409 at risk EG00116 affected1,409 at risk
Extremity necrosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG00110 affected1,409 at risk
Hypertensive crisis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00113 affected1,409 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG00112 affected1,409 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG0019 affected1,409 at risk
Aortic stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG0015 affected1,409 at risk
Deep vein thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0017 affected1,409 at risk
Orthostatic hypotension	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Haematoma	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0019 affected1,409 at risk
Shock haemorrhagic	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0015 affected1,409 at risk
Aortic aneurysm	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0015 affected1,409 at risk
Steal syndrome	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0018 affected1,409 at risk
Dry gangrene	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Intermittent claudication	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0013 affected1,409 at risk
Venous stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0014 affected1,409 at risk
Circulatory collapse	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Brachiocephalic vein stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Angiopathy	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Arterial disorder	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Hypovolaemic shock	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Vena cava thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Venous thrombosis limb	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Arterial occlusive disease	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Shock	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Angiodysplasia	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Aortic dissection	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Arterial haemorrhage	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Arterial rupture	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Arteriosclerosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Brachiocephalic vein thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic macroangiopathy	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Diabetic vascular disorder	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Haemorrhage	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Hypertensive emergency	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Leriche syndrome	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Peripheral embolism	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Phlebitis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Subclavian vein stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Thrombophlebitis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Vascular calcification	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Venous thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Aneurysm	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Aortic thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Arterial stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Femoral artery dissection	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Haemorrhagic infarction	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ischaemia	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ischaemic limb pain	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lymphatic fistula	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lymphoedema	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lymphostasis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Microangiopathy	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Microscopic polyangiitis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Varicose vein	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vascular stenosis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Vasculitis	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vasculitis necrotising	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Venous aneurysm	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ischaemic stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00028 affected1,409 at risk EG00121 affected1,409 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00023 affected1,409 at risk EG00124 affected1,409 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00017 affected1,409 at risk EG00130 affected1,409 at risk
Syncope	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00022 affected1,409 at risk EG00115 affected1,409 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Seizure	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG0015 affected1,409 at risk
Cerebral infarction	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0019 affected1,409 at risk
Dizziness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0019 affected1,409 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0013 affected1,409 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0016 affected1,409 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0013 affected1,409 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Dementia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Sciatica	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0013 affected1,409 at risk
Epilepsy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Headache	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Vascular dementia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Presyncope	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Thrombotic stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Altered state of consciousness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Cerebral haematoma	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Facial paralysis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Stupor	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Aphasia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Ataxia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Brain stem infarction	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Dyskinesia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Embolic stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Encephalopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Lacunar infarction	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Polyneuropathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Balance disorder	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Brain hypoxia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Brain injury	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cerebellar stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cerebral ataxia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cognitive disorder	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Dementia with Lewy bodies	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Demyelination	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Diabetic mononeuropathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Essential tremor	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Facial paresis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hemianopia homonymous	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hemiparesis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hypocalcaemic seizure	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ischaemic neuropathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
IVth nerve paresis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lacunar stroke	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lethargy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Loss of consciousness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Memory impairment	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Migraine	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Monoparesis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Movement disorder	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Myelopathy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Myoclonic epilepsy	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Nerve root compression	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nervous system disorder	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Noninfective encephalitis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Paraparesis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Retrograde amnesia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Somnolence	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Spinal subarachnoid haemorrhage	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Status epilepticus	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Tension headache	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Transient global amnesia	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Wallerian degeneration	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Death	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00033 affected1,409 at risk EG00139 affected1,409 at risk
Sudden death	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00026 affected1,409 at risk EG00144 affected1,409 at risk
Pyrexia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00030 affected1,409 at risk EG00126 affected1,409 at risk
General physical health deterioration	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00016 affected1,409 at risk EG00112 affected1,409 at risk
Chest pain	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG00110 affected1,409 at risk
Catheter site haemorrhage	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0017 affected1,409 at risk
Non-cardiac chest pain	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG0013 affected1,409 at risk
Asthenia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0012 affected1,409 at risk
Inflammation	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0015 affected1,409 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0013 affected1,409 at risk
Complication associated with device	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Sudden cardiac death	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Hyperthermia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0011 affected1,409 at risk
Adverse drug reaction	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
Device related thrombosis	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Hyperpyrexia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Malaise	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Oedema due to renal disease	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Fatigue	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Hernia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Oedema peripheral	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Swelling	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Catheter site inflammation	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Chest discomfort	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Gait disturbance	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Oedema	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Strangulated hernia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Accidental death	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Discomfort	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Drug intolerance	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dysplasia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Heteroplasia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Impaired healing	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Implant site extravasation	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Incarcerated hernia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Injection site extravasation	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Injection site scab	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Medical device pain	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mucosal ulceration	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Necrosis	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oedema due to cardiac disease	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pseudocyst	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Stent-graft endoleak	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Surgical failure	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Treatment failure	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vascular stent restenosis	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vascular stent stenosis	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Vascular stent thrombosis	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vessel puncture site haematoma	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00022 affected1,409 at risk EG00122 affected1,409 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00023 affected1,409 at risk EG00115 affected1,409 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00014 affected1,409 at risk EG00116 affected1,409 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00012 affected1,409 at risk EG00118 affected1,409 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00014 affected1,409 at risk EG00111 affected1,409 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00011 affected1,409 at risk EG00112 affected1,409 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG00113 affected1,409 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0018 affected1,409 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0015 affected1,409 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0008 affected1,409 at risk EG0014 affected1,409 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0016 affected1,409 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0015 affected1,409 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0017 affected1,409 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0010 affected1,409 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Acute lung injury	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mediastinal effusion	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mendelson's syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0018 affected1,409 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0016 affected1,409 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0014 affected1,409 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0013 affected1,409 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0016 affected1,409 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0015 affected1,409 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0016 affected1,409 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0010 affected1,409 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0014 affected1,409 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Acute myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Benign neoplasm of epididymis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Benign urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bladder transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Carcinoid tumour of the duodenum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Carcinoid tumour of the stomach	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Carcinoma in situ of penis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Central nervous system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cerebral hygroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cervix cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Connective tissue neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Ear neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Endometrial neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Extranodal marginal zone B-cell lymphoma (malt type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Laryngeal papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Malignant fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metastatic carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oligodendroglioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Paget's disease of nipple	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pelvic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Plasma cell myeloma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Rectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Refractory cytopenia with unilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Renal cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Renal haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Thymoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Transitional cell cancer of renal pelvis and ureter metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Transitional cell carcinoma urethra	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Urinary bladder adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG00044 affected1,409 at risk EG00143 affected1,409 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG00018 affected1,409 at risk EG00132 affected1,409 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG00012 affected1,409 at risk EG00117 affected1,409 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG00110 affected1,409 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0013 affected1,409 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0017 affected1,409 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0015 affected1,409 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0016 affected1,409 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0014 affected1,409 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0014 affected1,409 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0014 affected1,409 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Gout	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Hyperinsulinaemic hypoglycaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Metabolic disorder	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mitochondrial cytopathy	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Obesity	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
End stage renal disease	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG00031 affected1,409 at risk EG00126 affected1,409 at risk
Renal impairment	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG00020 affected1,409 at risk EG00118 affected1,409 at risk
Haematuria	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0014 affected1,409 at risk
Azotaemia	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0016 affected1,409 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0013 affected1,409 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Renal failure	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Renal colic	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Urinary retention	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Calculus urethral	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cystitis interstitial	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Kidney enlargement	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Lupus nephritis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Malnutrition-inflammation-atherosclerosis syndrome	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nephritis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Proteinuria	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Renal haematoma	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Renal ischaemia	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG00019 affected1,409 at risk EG00116 affected1,409 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0018 affected1,409 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG0012 affected1,409 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0012 affected1,409 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0013 affected1,409 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0014 affected1,409 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0014 affected1,409 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0010 affected1,409 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Arthrofibrosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Chronic kidney disease-mineral and bone disorder	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Collagen disorder	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
High turnover osteopathy	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Muscle necrosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Sarcopenia	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Sympathetic posterior cervical syndrome	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG00010 affected1,409 at risk EG00112 affected1,409 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG0017 affected1,409 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Cholangitis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0005 affected1,409 at risk EG0015 affected1,409 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Cholestasis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0010 affected1,409 at risk
Biliary colic	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Gallbladder enlargement	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Haemobilia	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hepatic artery stenosis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hepatotoxicity	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Jaundice	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Liver disorder	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Liver injury	Hepatobiliary disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG00017 affected1,409 at risk EG00117 affected1,409 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG00013 affected1,409 at risk EG00111 affected1,409 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Ischaemic skin ulcer	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Acute generalised exanthematous pustulosis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cholestatic pruritus	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Henoch-Schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Skin erosion	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vasculitic rash	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00022 affected1,409 at risk EG00125 affected1,409 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Anaemia of malignant disease	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Bone marrow toxicity	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Normochromic anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Spontaneous haemorrhage	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG00019 affected1,409 at risk EG00123 affected1,409 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0014 affected1,409 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Goitre	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Hypothyroidism	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0013 affected1,409 at risk
Basedow's disease	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Parathyroid hyperplasia	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Confusional state	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG00014 affected1,409 at risk EG00110 affected1,409 at risk
Delirium	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0013 affected1,409 at risk
Completed suicide	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Depression	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0012 affected1,409 at risk
Hallucination	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Sopor	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Adjustment disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Mania	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Mental status changes	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Organic brain syndrome	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Suicide attempt	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Acute psychosis	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Anxiety	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Anxiety disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Bipolar disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Drug abuse	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Mental disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Psychotic disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Device malfunction	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0007 affected1,409 at risk EG0018 affected1,409 at risk
Thrombosis in device	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0006 affected1,409 at risk EG0019 affected1,409 at risk
Device dislocation	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Device loosening	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0011 affected1,409 at risk
Device breakage	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Device damage	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Device extrusion	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Device failure	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Device occlusion	Product Issues	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Cataract	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0009 affected1,409 at risk EG00110 affected1,409 at risk
Vitreous haemorrhage	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Glaucoma	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Diabetic retinopathy	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Retinal artery occlusion	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Cataract diabetic	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Endocrine ophthalmopathy	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Ocular vasculitis	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Papilloedema	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Retinal neovascularisation	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Retinal vein thrombosis	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vision blurred	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Visual impairment	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vitreous haematoma	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0013 affected1,409 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0011 affected1,409 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Breast mass	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Hysterocele	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Drug hypersensitivity	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0012 affected1,409 at risk
Hypersensitivity	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0004 affected1,409 at risk EG0011 affected1,409 at risk
Anti-neutrophil cytoplasmic antibody positive vasculitis	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0011 affected1,409 at risk
Kidney transplant rejection	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Anaphylactic shock	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Graft versus host disease	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Immune reconstitution inflammatory syndrome	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Pancreas transplant rejection	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Sarcoidosis	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Transplant rejection	Immune system disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Vertigo	Ear and labyrinth disorders	MedDRA, Version 20.1	Systematic Assessment	EG0003 affected1,409 at risk EG0012 affected1,409 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA, Version 20.1	Systematic Assessment	EG0002 affected1,409 at risk EG0010 affected1,409 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Vertigo labyrinthine	Ear and labyrinth disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Weight decreased	Investigations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0013 affected1,409 at risk
International normalised ratio increased	Investigations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Coagulation time prolonged	Investigations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Investigation abnormal	Investigations	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Troponin increased	Investigations	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0012 affected1,409 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0012 affected1,409 at risk
Congenital bladder anomaly	Congenital, familial and genetic disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Nonketotic hyperglycinaemia	Congenital, familial and genetic disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA, Version 20.1	Systematic Assessment	EG0001 affected1,409 at risk EG0010 affected1,409 at risk
Oral surgery	Surgical and medical procedures	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG0000 affected1,409 at risk EG0011 affected1,409 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000171 affected1,409 at risk EG001187 affected1,409 at risk
Bronchitis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000195 affected1,409 at risk EG001188 affected1,409 at risk
Urinary tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000193 affected1,409 at risk EG001200 affected1,409 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000153 affected1,409 at risk EG001132 affected1,409 at risk
Gastroenteritis	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00093 affected1,409 at risk EG001101 affected1,409 at risk
Pneumonia	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG000101 affected1,409 at risk EG00179 affected1,409 at risk
Respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00076 affected1,409 at risk EG00170 affected1,409 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00055 affected1,409 at risk EG00174 affected1,409 at risk
Influenza	Infections and infestations	MedDRA, Version 20.1	Systematic Assessment	EG00083 affected1,409 at risk EG00172 affected1,409 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG000269 affected1,409 at risk EG001273 affected1,409 at risk
Constipation	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG000173 affected1,409 at risk EG001142 affected1,409 at risk
Vomiting	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG000146 affected1,409 at risk EG001121 affected1,409 at risk
Nausea	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00099 affected1,409 at risk EG001104 affected1,409 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00088 affected1,409 at risk EG001102 affected1,409 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00070 affected1,409 at risk EG00182 affected1,409 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00078 affected1,409 at risk EG00159 affected1,409 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000211 affected1,409 at risk EG001199 affected1,409 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000158 affected1,409 at risk EG001119 affected1,409 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000133 affected1,409 at risk EG001124 affected1,409 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000110 affected1,409 at risk EG001125 affected1,409 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000105 affected1,409 at risk EG00186 affected1,409 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG00079 affected1,409 at risk EG00172 affected1,409 at risk
Hypertension	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG000432 affected1,409 at risk EG001455 affected1,409 at risk
Hypotension	Vascular disorders	MedDRA, Version 20.1	Systematic Assessment	EG000143 affected1,409 at risk EG001124 affected1,409 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG000225 affected1,409 at risk EG001223 affected1,409 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG000171 affected1,409 at risk EG001158 affected1,409 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA, Version 20.1	Systematic Assessment	EG00087 affected1,409 at risk EG00186 affected1,409 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG000140 affected1,409 at risk EG001122 affected1,409 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG000142 affected1,409 at risk EG001136 affected1,409 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA, Version 20.1	Systematic Assessment	EG000130 affected1,409 at risk EG001115 affected1,409 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG000194 affected1,409 at risk EG001162 affected1,409 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG000109 affected1,409 at risk EG001109 affected1,409 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 20.1	Systematic Assessment	EG00072 affected1,409 at risk EG00150 affected1,409 at risk
Pyrexia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00096 affected1,409 at risk EG00192 affected1,409 at risk
Oedema due to renal disease	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00079 affected1,409 at risk EG00178 affected1,409 at risk
Asthenia	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00059 affected1,409 at risk EG00185 affected1,409 at risk
Oedema peripheral	General disorders	MedDRA, Version 20.1	Systematic Assessment	EG00073 affected1,409 at risk EG00161 affected1,409 at risk
Headache	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG000127 affected1,409 at risk EG001141 affected1,409 at risk
Dizziness	Nervous system disorders	MedDRA, Version 20.1	Systematic Assessment	EG00078 affected1,409 at risk EG00181 affected1,409 at risk
Insomnia	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG000116 affected1,409 at risk EG001104 affected1,409 at risk
Depression	Psychiatric disorders	MedDRA, Version 20.1	Systematic Assessment	EG00065 affected1,409 at risk EG00175 affected1,409 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA, Version 20.1	Systematic Assessment	EG000143 affected1,409 at risk EG001174 affected1,409 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA, Version 20.1	Systematic Assessment	EG000149 affected1,409 at risk EG001148 affected1,409 at risk
Atrial fibrillation	Cardiac disorders	MedDRA, Version 20.1	Systematic Assessment	EG000123 affected1,409 at risk EG001111 affected1,409 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA, Version 20.1	Systematic Assessment	EG000118 affected1,409 at risk EG001114 affected1,409 at risk
Cataract	Eye disorders	MedDRA, Version 20.1	Systematic Assessment	EG00072 affected1,409 at risk EG00176 affected1,409 at risk

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D001685	Biological Factors

ID	Title	Description
BG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
BG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Erythropoiesis Stimulating Agents	Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.	557	1,409	1,123	1,409	1,171	1,409
EG001	Methoxy Polyethylene Glycol-Epoetin Beta	Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin [Hb] 10-12 grams per deciliter [g/dL]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.	558	1,409	1,097	1,409	1,177	1,409

ID	Term
D000068256	Darbepoetin alfa
D000068817	Epoetin Alfa
C103998	epoetin beta
C508420	continuous erythropoietin receptor activator