Study Investigating a Standard Regimen in de Novo Kidney... | NCT00514514

ID	Type	Description	Link
2006-007021-32

Label	Type	Description	Intervention Names
CNI standard regimen	Active Comparator	Myfortic, Sandimmun Optoral and corticosteroids	Drug: Myfortic Drug: Sandimmun Optoral Drug: Simulect®
CNI free regimen	Experimental	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids	Drug: Everolimus Drug: Myfortic Drug: Sandimmun Optoral
CNI low regimen	Active Comparator	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids	Drug: Everolimus Drug: Sandimmun Optoral

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen	CNI free regimen

Measure	Description	Time Frame
GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen	Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted	From randomization at BL2 (Month 3) to Month 12 post-transplant

Measure	Description	Time Frame
GFR Via Nankivell Formula at Month 12 - All Regimens	Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Aachen		52074	Germany
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
30231851	Derived	Sommerer C, Witzke O, Lehner F, Arns W, Reinke P, Eisenberger U, Vogt B, Heller K, Jacobi J, Guba M, Stahl R, Hauser IA, Kliem V, Wuthrich RP, Muhlfeld A, Suwelack B, Duerr M, Paulus EM, Zeier M, Porstner M, Budde K; ZEUS and HERAKLES study investigators. Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials. BMC Nephrol. 2018 Sep 19;19(1):237. doi: 10.1186/s12882-018-1031-1.
28605781

ID	Title	Description
FG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
FG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids

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

GFR Via Nankivell Method at Month 12 - CNI-Free vs Standard Regimen

Demonstrate superiority of CNI-Free vs Standard Regimen in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate. P-values are not adjusted

Participants analyzed differs due to different input values requested by the different formulas (Nankivell, MDRD and Cockcroft-Gault). ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization.

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 12 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Units	Counts
Participants	OG000159 OG001163 OG002160

Title

Denominators

Categories

Title	Measurements
	OG00063.03(60.57 to 65.49) OG00168.59(66.10 to 71.08) OG00263.08(60.62 to 65.55)

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		ANCOVA		< 0.0001		Mean Difference (Net)	5.56			2-Sided	95	2.82	8.31				No	Superiority or Other

Secondary

GFR Via Nankivell Formula at Month 12 - All Regimens

Change in GFR using the Nankivell formula (GFR = 6.7 / Scr + BW / 4 - Surea / 2-100 / (height)² + C where where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kilograms, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The calculated GFR is expressed in mL/min per 1.73m², last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 12 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids

Secondary

GFR at Month 12 Utilizing Modification of Diet in Renal Disease (MDRD) Method

Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:

For men: GFR = 170 × (serum creatinine -0,999)×(age-0,176) x (urea nitrogen -0,17) × (albumin0,318) For women: GFR = 170 × (serum creatinine -0,999) × (age-0,176) × (urea nitrogen -0,17) x (albumin0,318) × 0.762 with urea nitrogen = urea / 2.144. ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model, with treatment, center, donor type (deceased vs. living) as factors and BL2-value at V4/M3/BL2 as covariate.

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 12 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids

Secondary

GFR at Month 12 Utilizing Cockcroft-Gault Formula

Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 12 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen

Secondary

Mean Change in Serum Creatinine From Month 3 to Month 12

Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

Participants analyzed required at least one post randomization value. ITT Population consisted of all patients who were randomized at Month 3 who received at least one dose of randomized treatment. The ITT population might have included patients without any data after randomization

Posted

Least Squares Mean

95% Confidence Interval

mg/dl

From randomization at BL2 (Month 3) to Month 12 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Secondary

Efficacy Event Data From Baseline 2 (Month 3) to Month 6

Efficacy events were: Biopsy-proven acute rejection (BPAR), graft loss, death, and treatment failure (defined as composite endpoint of BPAR, graft loss, death, loss to follow-up, discontinuation due to lack of efficacy or due to toxicity).

The Intention-to-treat (ITT) Population consisted of all patients who were randomized at BL2 (Month 3), and who received at least one dose of randomized treatment. Patients were analyzed according to their assigned treatment. The ITT population might have included patients without any data after randomization.

Posted

Number

Participants

From Baseline 2 (Month 3) to Month 6

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Secondary

Efficacy Event Data Baseline 2 (Month 3) to Month 12

Posted

Number

Participants

From Baseline 2 (Month 3) to Month 12

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Secondary

Change From BL2 (Month 3) to Month 12 in Cardiovascular Risk (Framingham Score; 10-year Cardiovascular Risk)

The Framingham Score (based on LDL cholesterol level) estimates the coronary heart disease risk (%) of developing one of the following coronary heart diseases: angina pectoris, myocardial infarction, or coronary disease death, over the course of 10 years.

Posted

Mean

Standard Deviation

Percent risk

From Baseline 2 (Month 3) to Month 12

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Secondary

GFR Calculated Via Nankivell Formula at Month 60

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 60

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids

Secondary

GFR at Month 60 Utilizing Cockcroft-Gault Formula

Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl) For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 60 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen

Secondary

GFR at Month 60 Utilizing Modification of Diet in Renal Disease (MDRD) Method

Change in GFR (Modification of Diet in Renal Disease calculated using the -MDRD formulat:

Posted

Least Squares Mean

95% Confidence Interval

ml/min/1.73m²

From randomization at BL2 (Month 3) to Month 60 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids

Secondary

Mean Change in Serum Creatinine From Month 3 to Month 60

Change in venous blood serum creatinine. Last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model

Participants analyzed were previously enrolled in the core study and had at least one serum creatinine value in the extension period.

Posted

Least Squares Mean

95% Confidence Interval

mg/dl

From randomization at BL2 (Month 3) to Month 60 post-transplant

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Secondary

Efficacy Event Data After Month 12 to Month 60

Posted

Number

Participants

Events starting after Month 12

ID	Title	Description
OG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
OG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
OG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
AGRANULOCYTOSIS	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ANAEMIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
BONE MARROW OEDEMA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
LEUKOPENIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0014 affected171 at risk EG0021 affected161 at risk
NEPHROGENIC ANAEMIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
POLYCYTHAEMIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
ANGINA PECTORIS	Cardiac disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ATRIAL FIBRILLATION	Cardiac disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected171 at risk EG0021 affected161 at risk
ATRIAL FLUTTER	Cardiac disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
BRADYCARDIA	Cardiac disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CARDIAC FAILURE	Cardiac disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
VERTIGO	Ear and labyrinth disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CATARACT	Eye disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
OPTIC ISCHAEMIC NEUROPATHY	Eye disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ASCITES	Gastrointestinal disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
COLITIS	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
DIARRHOEA	Gastrointestinal disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0015 affected171 at risk EG0024 affected161 at risk
GASTRITIS	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
HAEMORRHOIDS	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
NAUSEA	Gastrointestinal disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
NONINFECTIOUS PERITONITIS	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
RECTAL PERFORATION	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
VOMITING	Gastrointestinal disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ATROPHY	General disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
CHILLS	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
DEVICE DISLOCATION	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
GENERALISED OEDEMA	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
IMPAIRED HEALING	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
LOCALISED OEDEMA	General disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
MULTI-ORGAN FAILURE	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
OEDEMA PERIPHERAL	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
PYREXIA	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0013 affected171 at risk EG0024 affected161 at risk
SUDDEN CARDIAC DEATH	General disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
CHOLELITHIASIS	Hepatobiliary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
KIDNEY TRANSPLANT REJECTION	Immune system disorders	18.0	Systematic Assessment	EG0005 affected165 at risk EG0016 affected171 at risk EG0024 affected161 at risk
TRANSPLANT REJECTION	Immune system disorders	18.0	Systematic Assessment	EG0006 affected165 at risk EG00113 affected171 at risk EG0029 affected161 at risk
ANORECTAL INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
APPENDICITIS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ATYPICAL PNEUMONIA	Infections and infestations	18.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
BK VIRUS INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
BRONCHITIS	Infections and infestations	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
BRONCHOPNEUMONIA	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
CANDIDA INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CYSTITIS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CYTOMEGALOVIRUS GASTROENTERITIS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0006 affected165 at risk EG0011 affected171 at risk EG0024 affected161 at risk
CYTOMEGALOVIRUS VIRAEMIA	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
DIABETIC GANGRENE	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
DIARRHOEA INFECTIOUS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
ENCEPHALITIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
EPSTEIN-BARR VIRUS INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ESCHERICHIA INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
FEBRILE INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
GANGRENE	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
GASTROENTERITIS	Infections and infestations	18.0	Systematic Assessment	EG0003 affected165 at risk EG0016 affected171 at risk EG0022 affected161 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0022 affected161 at risk
GROIN ABSCESS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HAEMATOMA INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HERPES ZOSTER	Infections and infestations	18.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0004 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
INFLUENZA	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
KIDNEY INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
NECROTISING FASCIITIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PNEUMONIA	Infections and infestations	18.0	Systematic Assessment	EG0003 affected165 at risk EG0016 affected171 at risk EG0024 affected161 at risk
PNEUMONIA CYTOMEGALOVIRAL	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
PNEUMONIA INFLUENZAL	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PNEUMONIA STREPTOCOCCAL	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PSEUDOMEMBRANOUS COLITIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
PYELONEPHRITIS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PYONEPHROSIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
RENAL CYST INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SALPINGO-OOPHORITIS	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SEPSIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
SEPTIC SHOCK	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
SHUNT INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SINUSITIS	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
URINARY TRACT INFECTION	Infections and infestations	18.0	Systematic Assessment	EG00015 affected165 at risk EG00112 affected171 at risk EG0027 affected161 at risk
UROSEPSIS	Infections and infestations	18.0	Systematic Assessment	EG0006 affected165 at risk EG0012 affected171 at risk EG0027 affected161 at risk
VARICELLA	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
VIRAL INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
WOUND INFECTION	Infections and infestations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ACCIDENT	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
COMPLICATIONS OF TRANSPLANT SURGERY	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
COMPLICATIONS OF TRANSPLANTED KIDNEY	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0005 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
CONTUSION	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
GRAFT LOSS	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
HEAT STROKE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
KIDNEY RUPTURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
OVERDOSE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
RENAL LYMPHOCELE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SEROMA	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SHUNT OCCLUSION	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
TRANSPLANT DYSFUNCTION	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
TRANSPLANT FAILURE	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0003 affected165 at risk EG0015 affected171 at risk EG0023 affected161 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
VENA CAVA INJURY	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
BLOOD CREATININE INCREASED	Investigations	18.0	Systematic Assessment	EG00014 affected165 at risk EG00114 affected171 at risk EG00217 affected161 at risk
CARBOHYDRATE ANTIGEN 125 INCREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
CREATININE URINE INCREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
CYTOMEGALOVIRUS TEST	Investigations	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CYTOMEGALOVIRUS TEST POSITIVE	Investigations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
HAEMOGLOBIN DECREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HEPATIC ENZYME INCREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
IMMUNOSUPPRESSANT DRUG LEVEL INCREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
RED BLOOD CELL ACANTHOCYTES PRESENT	Investigations	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
WEIGHT INCREASED	Investigations	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
DEHYDRATION	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0022 affected161 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
TUMOUR LYSIS SYNDROME	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
ARTHROPATHY	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
NEUROPATHIC ARTHROPATHY	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
POST TRANSPLANT DISTAL LIMB SYNDROME	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
CLEAR CELL RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
OVARIAN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
SKIN PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
APHASIA	Nervous system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
CEREBRAL INFARCTION	Nervous system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
HEADACHE	Nervous system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
HEMIPARESIS	Nervous system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
POLYNEUROPATHY	Nervous system disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PRESYNCOPE	Nervous system disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
ADJUSTMENT DISORDER	Psychiatric disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
DEPRESSION	Psychiatric disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PANIC ATTACK	Psychiatric disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
RESTLESSNESS	Psychiatric disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0022 affected161 at risk
GLOMERULOSCLEROSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
HAEMATURIA	Renal and urinary disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
HYDRONEPHROSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
KIDNEY FIBROSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
NEPHRECTASIA	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
NEPHROLITHIASIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
NEPHROPATHY	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PROTEINURIA	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0013 affected171 at risk EG0021 affected161 at risk
REFLUX NEPHROPATHY	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
RENAL CYST RUPTURED	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
RENAL FAILURE	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
RENAL INFARCT	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
RENAL TUBULAR ATROPHY	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0022 affected161 at risk
URETERIC STENOSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
URETHRAL OBSTRUCTION	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
URETHRAL STENOSIS	Renal and urinary disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
URINARY RETENTION	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
VESICOURETERIC REFLUX	Renal and urinary disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
OVARIAN CYST	Reproductive system and breast disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0020 affected161 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ALVEOLITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0013 affected171 at risk EG0020 affected161 at risk
PLEURAL FIBROSIS	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0022 affected161 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
RESUSCITATION	Surgical and medical procedures	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
ARTERIAL THROMBOSIS	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
ARTERIOSCLEROSIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0012 affected171 at risk EG0021 affected161 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
EMBOLISM	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
EMBOLISM ARTERIAL	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
HYPERTENSION	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0021 affected161 at risk
HYPERTENSIVE CRISIS	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
LYMPHOCELE	Vascular disorders	18.0	Systematic Assessment	EG0002 affected165 at risk EG0011 affected171 at risk EG0024 affected161 at risk
LYMPHOEDEMA	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
PERIPHERAL ARTERY STENOSIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
THROMBOPHLEBITIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
THROMBOSIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0023 affected161 at risk
VASCULITIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk
VENOUS ANEURYSM	Vascular disorders	18.0	Systematic Assessment	EG0001 affected165 at risk EG0010 affected171 at risk EG0020 affected161 at risk
VENOUS OCCLUSION	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
VENOUS THROMBOSIS	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0010 affected171 at risk EG0021 affected161 at risk
VENOUS THROMBOSIS LIMB	Vascular disorders	18.0	Systematic Assessment	EG0000 affected165 at risk EG0011 affected171 at risk EG0020 affected161 at risk

ID	Term
D000068338	Everolimus
D009173	Mycophenolic Acid
D016572	Cyclosporine
D000077552	Basiliximab

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids
BG001	CNI Free Regimen	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids
BG002	CNI Low Regimen	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard Regimen	Myfortic, Sandimmun Optoral and corticosteroids	87	165	121	165
EG001	CNI-free	CNI free regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids	91	171	134	171
EG002	CNI-low	CNI low regimen: comprising the following steps for switching treatment: Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids	85	161	133	161