Advancing Renal TRANSplant eFficacy and Safety Outcomes W... | NCT01950819

ID	Type	Description	Link
2013-000322-66	EudraCT Number

Label	Type	Description	Intervention Names
EVR+rCNI	Experimental	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)	Biological: Induction therapy Drug: Corticosteroids Drug: EVR+rCNI
MPA+sCNI	Active Comparator	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).	Biological: Induction therapy Drug: Corticosteroids Drug: MPA+sCNI

Name	Type	Description	Arm Group Labels	Other Names
Induction therapy	Biological	All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.	EVR+rCNI

Measure	Description	Time Frame
Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.	Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.	Month 12 is Primary, Month 24 secondary

Measure	Description	Time Frame
Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death	Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death	Month 12 and 24
Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

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

PubMed Identifier	Type	Citation	Retractions
34620664	Derived	Aubert O, Divard G, Pascual J, Oppenheimer F, Sommerer C, Citterio F, Tedesco H, Chadban S, Henry M, Vincenti F, Srinivas T, Watarai Y, Legendre C, Bernhardt P, Loupy A. Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study. BMJ Open. 2021 Oct 7;11(10):e052138. doi: 10.1136/bmjopen-2021-052138.
34216395

ID	Title	Description
FG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
FG001	MPA+sCNI

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 14, 2016	Jan 9, 2019

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

Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.

full analysis set

Posted

Count of Participants

Participants

Month 12 is Primary, Month 24 secondary

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG0001022 OG0011015

Title

Denominators

Categories

month 12

Title	Measurements
	OG000489 OG001456

month 24

Title	Measurements
	OG000

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	calculated at month 12	Logistic Regression Model		0.001		Odds Ratio (OR)	3.0			2-Sided	95	-1.4	7.3					Non-Inferiority	p vale for non inferiority margin is 10 %

Secondary

Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2

Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Failure on the Composite Endpoint of Graft Loss or Death.

Incidence of failure on the composite endpoint of graft loss or death.

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection

Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of eGFR < 50 mL/Min/1.73m2

Incidence of eGFR < 50 mL/min/1.73m2

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR

Renal allograft function : mean estimated glomerular filtration rate, eGFR

full analysis set

Posted

Mean

Standard Error

mL/min/1.73m2

Baseline (week 4), Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.

Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.

full analysis set

Posted

Mean

Standard Error

mL / min / 1.73m2 / day

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Renal Function Assessed by Creatinine Lab Values

Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.

full analysis set with measure

Posted

Mean

Standard Deviation

micromol/L

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported

Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.

full analysis set with measure

Posted

Mean

Standard Deviation

mL/min/1.73m2

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.

Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.

safety set 24 months analysis

Posted

Count of Participants

Participants

Month 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.

Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.

safety set

Posted

Count of Participants

Participants

Month 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.

Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.

safety set with measure

Posted

Mean

Standard Deviation

mg/g

Baseline, Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Major Cardiovascular Events.

Incidence of major cardiovascular events by Preferred Term

safety set

Posted

Count of Participants

Participants

Month 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Malignancies.

Incidence of malignancies.

safety set

Posted

Count of Participants

Participants

Month 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.

Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.

compliance set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)

Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:

Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IIA - Mild to moderate intimal arteritis
Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Secondary

Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)

Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IIA - Mild to moderate intimal arteritis
Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)

full analysis set

Posted

Number

events

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Secondary

Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections

Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:

Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).
Type IIA - Mild to moderate intimal arteritis
Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area
Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Secondary

Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup

Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2

Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Secondary

Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up

Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up

full analysis set

Posted

Count of Participants

Participants

Month 12 and 24

ID	Title	Description
OG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
OG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG00014 affected1,014 at risk EG0016 affected1,012 at risk
Atypical haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0015 affected1,012 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG00112 affected1,012 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Lymphatic obstruction	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0016 affected1,012 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected1,014 at risk EG0013 affected1,012 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0012 affected1,012 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0016 affected1,012 at risk
Angina pectoris	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0015 affected1,012 at risk
Angina unstable	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arrhythmia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG00012 affected1,014 at risk EG00112 affected1,012 at risk
Atrial flutter	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0011 affected1,012 at risk
Bradycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Cardiac arrest	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0014 affected1,012 at risk
Cardiac asthma	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cardiac dysfunction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cardiac failure	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG0017 affected1,012 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0013 affected1,012 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Coronary artery disease	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0016 affected1,012 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Left ventricular failure	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Myocardial infarction	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0016 affected1,012 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pericarditis	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Tachycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Congenital megaureter	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mastoid effusion	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Goitre	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cataract	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Glaucoma	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Retinal detachment	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Vision blurred	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Visual acuity reduced	Eye disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0012 affected1,012 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG00114 affected1,012 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0013 affected1,012 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Anal polyp	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Colitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Constipation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG00027 affected1,014 at risk EG00155 affected1,012 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Duodenal perforation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Encapsulating peritoneal sclerosis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Enteritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastritis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0014 affected1,012 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ileus	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0012 affected1,012 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0015 affected1,012 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0011 affected1,012 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Melaena	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Nausea	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0019 affected1,012 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Retching	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0015 affected1,012 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Salivary gland enlargement	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0014 affected1,012 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Volvulus	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Vomiting	Gastrointestinal disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG00113 affected1,012 at risk
Asthenia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Catheter site haemorrhage	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Chest discomfort	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Chest pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Chills	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Death	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Fatigue	General disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Gait inability	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
General physical health deterioration	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Generalised oedema	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hyperthermia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypothermia	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ill-defined disorder	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Impaired healing	General disorders	MedDRA (20.1)	Systematic Assessment	EG00010 affected1,014 at risk EG0011 affected1,012 at risk
Malaise	General disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Medical device site discomfort	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Medical device site inflammation	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Microlithiasis	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Non-cardiac chest pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Oedema peripheral	General disorders	MedDRA (20.1)	Systematic Assessment	EG0007 affected1,014 at risk EG0014 affected1,012 at risk
Pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Peripheral swelling	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Pyrexia	General disorders	MedDRA (20.1)	Systematic Assessment	EG00035 affected1,014 at risk EG00136 affected1,012 at risk
Sudden death	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Suprapubic pain	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Swelling	General disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hepatocellular injury	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Perforation bile duct	Hepatobiliary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Chronic allograft nephropathy	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hypersensitivity	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Immunosuppression	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Kidney transplant rejection	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG00018 affected1,014 at risk EG00117 affected1,012 at risk
Renal transplant failure	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0015 affected1,012 at risk
Transplant rejection	Immune system disorders	MedDRA (20.1)	Systematic Assessment	EG00045 affected1,014 at risk EG00125 affected1,012 at risk
Abdominal abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Abdominal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Actinomycosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Adenoviral haemorrhagic cystitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Adenovirus infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Anal abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Appendicitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Arteriovenous fistula site infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arthritis bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arthritis infective	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Atypical pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
BK virus infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0015 affected1,012 at risk
Bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bacterial infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bacterial prostatitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Bacterial sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Bacteriuria	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Blister infected	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Candida infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Candiduria	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cellulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0016 affected1,012 at risk
Chest wall abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Chronic sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Chronic tonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0013 affected1,012 at risk
Clostridium difficile infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Corona virus infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cryptococcosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Cystitis viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0019 affected1,012 at risk
Cytomegalovirus enteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cytomegalovirus gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Cytomegalovirus gastrointestinal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cytomegalovirus hepatitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG00148 affected1,012 at risk
Dengue fever	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Dermatophytosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Device related infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Device related sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Diabetic foot infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Disseminated tuberculosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Diverticulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0013 affected1,012 at risk
Ear infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Encephalitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Endocarditis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Enteritis infectious	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Enterococcal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Enterococcal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Enterocolitis viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Epididymitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Erysipelas	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Escherichia infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Escherichia sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0011 affected1,012 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0017 affected1,012 at risk
Febrile infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Fungal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Fungal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Gangrene	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Gastroenteritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00018 affected1,014 at risk EG00123 affected1,012 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0016 affected1,012 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Groin abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0012 affected1,012 at risk
HIV infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haematoma infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Hepatic cyst infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hepatitis C	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hepatitis E	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hepatitis viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Herpes simplex	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Herpes simplex pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Herpes zoster	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0014 affected1,012 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ileal gangrene	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Infected lymphocele	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0011 affected1,012 at risk
Infected seroma	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Infected skin ulcer	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0012 affected1,012 at risk
Infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Infectious colitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Infectious pleural effusion	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Influenza	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0015 affected1,012 at risk
Intervertebral discitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Intestinal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Kidney infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Klebsiella bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Klebsiella sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Lung infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Medical device site cellulitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Medical device site infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Meningitis bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Nasopharyngitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Neutropenic sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Nocardiosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Oral candidiasis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Oral herpes	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Orchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Osteomyelitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0012 affected1,012 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Parvovirus B19 infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Perinephric abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Peritonitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0013 affected1,012 at risk
Pneumonia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00055 affected1,014 at risk EG00136 affected1,012 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0014 affected1,012 at risk
Pneumonia fungal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pneumonia haemophilus	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pneumonia influenzal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pneumonia legionella	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG00110 affected1,012 at risk
Postoperative abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Postoperative wound infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0013 affected1,012 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Pyelonephritis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00024 affected1,014 at risk EG00133 affected1,012 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG00113 affected1,012 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Pyuria	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal cyst infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Renal graft infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0015 affected1,012 at risk
Respiratory tract infection fungal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Rhinitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Rhinovirus infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Salmonellosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00020 affected1,014 at risk EG0017 affected1,012 at risk
Septic shock	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG0018 affected1,012 at risk
Sinusitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Sinusitis fungal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Systemic candida	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tooth abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Tracheobronchitis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Transplant abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tuberculosis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tuberculosis gastrointestinal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0014 affected1,012 at risk
Urinary tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00078 affected1,014 at risk EG00193 affected1,012 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0011 affected1,012 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Urosepsis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG00023 affected1,014 at risk EG00123 affected1,012 at risk
Varicella	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Viral diarrhoea	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Viral infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Viral myocarditis	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Wound abscess	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Wound infection	Infections and infestations	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0014 affected1,012 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Aponeurosis contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arteriovenous fistula aneurysm	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0014 affected1,012 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG00034 affected1,014 at risk EG00128 affected1,012 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Coronary bypass stenosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Delayed graft function	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0007 affected1,014 at risk EG0012 affected1,012 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Graft haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Graft loss	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG00016 affected1,014 at risk EG00112 affected1,012 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0008 affected1,014 at risk EG0011 affected1,012 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Musculoskeletal injury	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Peripheral arterial reocclusion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0014 affected1,012 at risk
Post procedural persistent drain fluid	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Renal lymphocele	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Renal transplant torsion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Scar	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0012 affected1,012 at risk
Shunt aneurysm	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0014 affected1,012 at risk
Transplant dysfunction	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0007 affected1,014 at risk EG0017 affected1,012 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Transplantation complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0011 affected1,012 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ureteric anastomosis complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Urinary anastomotic leak	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Vascular graft stenosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Wound decomposition	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG00010 affected1,014 at risk EG0013 affected1,012 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Alanine aminotransferase increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Biopsy kidney	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Blood creatine increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Blood creatinine abnormal	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Blood creatinine increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG00050 affected1,014 at risk EG00136 affected1,012 at risk
Blood glucose increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Blood phosphorus decreased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Blood urea increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
C-reactive protein increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Catheterisation cardiac	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ejection fraction abnormal	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haemoglobin decreased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haptoglobin decreased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Immunosuppressant drug level increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Inflammatory marker increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Liver function test increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Norovirus test positive	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Occult blood positive	Investigations	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Polyomavirus test positive	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Transaminases increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Troponin increased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Urine output decreased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Weight decreased	Investigations	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Calciphylaxis	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0006 affected1,014 at risk EG00111 affected1,012 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG00110 affected1,012 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0012 affected1,012 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0013 affected1,012 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Gout	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0005 affected1,014 at risk EG0016 affected1,012 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG00011 affected1,014 at risk EG00110 affected1,012 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0015 affected1,012 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0015 affected1,012 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0014 affected1,012 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0012 affected1,012 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG0011 affected1,012 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pubic pain	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG00010 affected1,014 at risk EG0014 affected1,012 at risk
Benign gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0013 affected1,012 at risk
Bronchioloalveolar carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cerebral haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Epstein-Barr virus associated lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Leydig cell tumour of the testis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0011 affected1,012 at risk
Malignant neoplasm of pleura metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Papillary tumour of renal pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0008 affected1,014 at risk EG0014 affected1,012 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0015 affected1,012 at risk
Testicular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Tumour of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ataxia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Autoimmune encephalopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Brain injury	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Brain stem infarction	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Central nervous system lesion	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cerebellar stroke	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Cerebral infarction	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Coma	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Dizziness	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Encephalopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Headache	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0017 affected1,012 at risk
Hyponatraemic seizure	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypotonia	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Migraine	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Myelitis transverse	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Neurotoxicity	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Presyncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Sciatica	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Seizure	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Spinal cord compression	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Syncope	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Transverse sinus thrombosis	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Tremor	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Visual field defect	Nervous system disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cephalhaematoma	Pregnancy, puerperium and perinatal conditions	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Device dislocation	Product Issues	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Device leakage	Product Issues	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Device malfunction	Product Issues	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Acute psychosis	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Aggression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Anxiety	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Depression	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mental disorder	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mental status changes	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Suicide attempt	Psychiatric disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG00046 affected1,014 at risk EG00137 affected1,012 at risk
Anuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Bladder obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Bladder perforation	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Dysuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0015 affected1,012 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Glomerulonephritis chronic	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Glomerulonephritis membranoproliferative	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Glycosuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Haematuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG00114 affected1,012 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG0016 affected1,012 at risk
Hydroureter	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
IgM nephropathy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ischaemic nephropathy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Leukocyturia	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Mesangioproliferative glomerulonephritis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Nephritis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Nephropathy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Obstructive nephropathy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Oliguria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Perinephric collection	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0015 affected1,012 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Prerenal failure	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Proteinuria	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG00015 affected1,014 at risk EG0013 affected1,012 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Renal artery dissection	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Renal artery occlusion	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0017 affected1,012 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Renal cortical necrosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Renal cyst	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal cyst haemorrhage	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal failure	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Renal haematoma	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Renal impairment	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG00023 affected1,014 at risk EG00125 affected1,012 at risk
Renal ischaemia	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal necrosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Renal tubular atrophy	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0015 affected1,012 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Ureteric dilatation	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0011 affected1,012 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0016 affected1,012 at risk
Urethral obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Urge incontinence	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Urinary fistula	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0012 affected1,012 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0009 affected1,014 at risk EG0011 affected1,012 at risk
Urinary retention	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0018 affected1,012 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0014 affected1,012 at risk
Urinoma	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Acquired hydrocele	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0013 affected1,012 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0014 affected1,012 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Testicular oedema	Reproductive system and breast disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0014 affected1,012 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0008 affected1,014 at risk EG0017 affected1,012 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0012 affected1,012 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0004 affected1,014 at risk EG0010 affected1,012 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG00017 affected1,014 at risk EG0016 affected1,012 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0012 affected1,012 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0014 affected1,012 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Capillaritis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Peau d'orange	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Skin oedema	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Loss of personal independence in daily activities	Social circumstances	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Walking disability	Social circumstances	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Orchidectomy	Surgical and medical procedures	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Accelerated hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Aortic aneurysm	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Aortic perforation	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Arterial stenosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arterial thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Arteriovenous fistula	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Artery dissection	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG00020 affected1,014 at risk EG00112 affected1,012 at risk
Embolism venous	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Haematoma	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0016 affected1,012 at risk
Hypertensive crisis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0015 affected1,012 at risk
Hypertensive emergency	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Hypotension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0018 affected1,012 at risk
Intermittent claudication	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Lymphocele	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG00034 affected1,014 at risk EG00121 affected1,012 at risk
Lymphorrhoea	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0003 affected1,014 at risk EG0010 affected1,012 at risk
Malignant hypertension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0011 affected1,012 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0012 affected1,012 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0011 affected1,012 at risk
Phlebitis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0012 affected1,012 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0002 affected1,014 at risk EG0010 affected1,012 at risk
Varicose ulceration	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0010 affected1,012 at risk
Venous stenosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk
Venous thrombosis	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0001 affected1,014 at risk EG0013 affected1,012 at risk
Venous thrombosis limb	Vascular disorders	MedDRA (20.1)	Systematic Assessment	EG0000 affected1,014 at risk EG0011 affected1,012 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Everolimus Plus@Reduced CNI	Everolimus plus@reduced CNI	20	1,014	593	1,014	951	1,014
EG001	MPA Plus Standard@CNI	MPA plus standard@CNI	29	1,012	613	1,012	942	1,012

ID	Term
D007676	Kidney Failure, Chronic
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency

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

ID	Term
D020360	Neoadjuvant Therapy
D000077552	Basiliximab
C512542	thymoglobulin
D000305	Adrenal Cortex Hormones
D011241	Prednisone
D008775	Methylprednisolone
D000068338	Everolimus
D016572	Cyclosporine
D016559	Tacrolimus
D009173	Mycophenolic Acid

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011239	Prednisolone
D011246	Pregnadienetriols
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D010455	Peptides
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Title	Description
BG000	EVR+rCNI	Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
BG001	MPA+sCNI	Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
BG002	Total	Total of all reporting groups