24 Months Follow-up, Two Arm Study to Compare the Cardiov... | NCT01169701

ID	Type	Description	Link
2009-013780-19	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tacrolimus	Active Comparator	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).	Drug: Tacrolimus Drug: Mycophenolic acid (MPA)
Everolimus	Experimental	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.	Drug: Everolimus Drug: Tacrolimus Drug: Mycophenolic acid (MPA)

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.	Everolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Left Ventricular Mass Index (LVMI)	Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.	Baseline, Month 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure	Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.	Baseline, Month 6, month 12, month 24
Pulse Wave Velocity (PWV)

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Málaga	Andalusia	29010	Spain
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
27648523	Derived	Cruzado JM, Pascual J, Sanchez-Fructuoso A, Seron D, Diaz JM, Rengel M, Oppenheimer F, Hernandez D, Paravisini A, Saval N, Morales JM; Evita Study Group. Controlled randomized study comparing the cardiovascular profile of everolimus with tacrolimus in renal transplantation. Transpl Int. 2016 Dec;29(12):1317-1328. doi: 10.1111/tri.12862. Epub 2016 Oct 17.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
FG001	Everolimus

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
BG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00036 BG00135 BG00271

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

Change From Baseline in Left Ventricular Mass Index (LVMI)

Left ventricular hypertrophy grade was assessed by echocardiogram where the left ventricular mass index was calculated. The presence of LVM was defined as > 49.2 g/m^2.7 in men and >46.7 g/m^2.7 in women. A negative change from baseline indicates improvement.

Participants from the Intent to Treat (ITT) analysis set, who had both baseline and month 24 values, were analyzed. The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.

Posted

Mean

Standard Deviation

g/m^2.7

Baseline, Month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Units	Counts
Participants	OG00031 OG00125

Title

Denominators

Categories

Title	Measurements
	OG000-6.071± 20.116 OG001-4.008± 17.610

Secondary

Change From Baseline in Mean 24 Hour Systolic and Diastolic Blood Pressure

Blood pressure was measured using ambulatory blood pressure monitoring (ABPM). A negative change from baseline indicates improvement.

Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at both baseline and the given time point, were analyzed for that time point.

Posted

Mean

Standard Deviation

mmHg

Baseline, Month 6, month 12, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Pulse Wave Velocity (PWV)

Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity.

Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.

Posted

Mean

Standard Deviation

m/sec

Month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Percentage of Participants With Major Cardiovascular Events (MACE)

The percentage of participants who experienced MACE were reported. MACE included acute myocardial infarction, insertion or replacement of implantable defibrillator, peripheral vascular disorders, congestive heart failure, coronary artery bypass, other events, percutaneous coronary intervention and stroke.

The Intent to Treat (ITT) analysis set: The ITT included participants who received at least one dose of study medication and had at least one post baseline LVMI value.

Posted

Number

Percentage of participants

Month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Renal Function Measured by Serum Creatinine

Serum samples were collected to analyze serum creatinine.

Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.

Posted

Mean

Standard Deviation

mg/dl

Month 6, month 12, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Units

Secondary

Renal Function as Measured by Creatinine Clearance

Creatinine clearance was calculated using the Cockroft-Gault formula.

Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.

Posted

Mean

Standard Deviation

mg/min

Month 6, month 12, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)

Estimated GFR was caluclated using the modification of diet in renal disease (MDRD) formula.

Participants from the safety analysis set were considered for this analysis. The safety analysis set included participants who received at least one dose of study medication. For each time point, only participants, who had values at the given time point, were analyzed for that time point.

Posted

Mean

Standard Deviation

mL/min/1.73m^2

Month 6, month 12, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in Cardiovascular Biomarkers: Troponin I and Collagen Type 1 C-telopeptide (ICTP)

Blood samples were collected to analyze Troponin I and collagen type 1 C-telopeptide (ICTP). A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

ng/ml

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in the Cardiovascular Biomarker, Glycosylated Hemoglobin (HbA1c)

Blood samples were collected to analyze HbA1c. A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in the Cardiovascular Biomarker, Myeloperoxidase (MPO)

Blood samples were collected to analyze MPO. A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

U/mL

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in the Cardiovascular Biomarker, N-terminal Pro-brain Natriuretic Peptide Fraction (NT-proBNP)

Blood samples were collected to analyze NT-proBNP. A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

pg/mL

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in the Cardiovascular Biomarker, Type 1 Procollagen Amino-terminal-propeptide (PINP)

Blood samples were collected to analyze PCR. A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

ug/l

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Change From Baseline in Cardiovascular Biomarkers, C-reactive Protein (CRP)

Blood samples were collected to analyze CRP. A negative change from baseline indicates improvement.

Posted

Mean

Standard Deviation

mg/dl

Baseline, month 6, month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Secondary

Percentage of Participants With Biopsy-proven Acute Rejection (BPAR), Graft Loss, Death and Lost to Follow up

The incidence of BPAR, graft loss, death and lost to follow-up events was calculated using relative frequency.

Intent to Treat (ITT): The ITT included participants who received at least one dose of study medication and at least one post baseline LVMI value.

Posted

Number

Percentage of participants

Month 24

ID	Title	Description
OG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
OG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tacrolimus	Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).			5	36	21	36
EG001	Everolimus	Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.			8	35	24	35

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pyrexia	General disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0010 affected35 at risk
Drug hypersensitivity	Immune system disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Oral herpes	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Pneumonia	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Pyelonephritis	Infections and infestations	17.0	Systematic Assessment	EG0001 affected36 at risk EG0010 affected35 at risk
Respiratory syncytial virus infection	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Septic shock	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Urosepsis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.0	Systematic Assessment	EG0001 affected36 at risk EG0010 affected35 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.0	Systematic Assessment	EG0001 affected36 at risk EG0010 affected35 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Cerebrovascular accident	Nervous system disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0010 affected35 at risk
Haematuria	Renal and urinary disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Renal impairment	Renal and urinary disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Urinary tract obstruction	Renal and urinary disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0011 affected35 at risk
Arteriovenous fistula operation	Surgical and medical procedures	17.0	Systematic Assessment	EG0000 affected36 at risk EG0011 affected35 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0013 affected35 at risk
Leukopenia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Polycythaemia	Blood and lymphatic system disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0012 affected35 at risk
Aphthous stomatitis	Gastrointestinal disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0013 affected35 at risk
Diarrhoea	Gastrointestinal disorders	17.0	Systematic Assessment	EG0004 affected36 at risk EG0013 affected35 at risk
Asthenia	General disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0010 affected35 at risk
Oedema peripheral	General disorders	17.0	Systematic Assessment	EG0003 affected36 at risk EG0016 affected35 at risk
Bronchitis	Infections and infestations	17.0	Systematic Assessment	EG0002 affected36 at risk EG0010 affected35 at risk
Escherichia urinary tract infection	Infections and infestations	17.0	Systematic Assessment	EG0004 affected36 at risk EG0014 affected35 at risk
Nasopharyngitis	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Pneumonia	Infections and infestations	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Respiratory tract infection	Infections and infestations	17.0	Systematic Assessment	EG0001 affected36 at risk EG0012 affected35 at risk
Urinary tract infection	Infections and infestations	17.0	Systematic Assessment	EG0007 affected36 at risk EG0011 affected35 at risk
Urinary tract infection bacterial	Infections and infestations	17.0	Systematic Assessment	EG0001 affected36 at risk EG0012 affected35 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Dyslipidaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0011 affected35 at risk
Hypercalcaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0003 affected36 at risk EG0011 affected35 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0012 affected35 at risk
Hyperglycaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0012 affected35 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0011 affected35 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0010 affected35 at risk
Dizziness	Nervous system disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Headache	Nervous system disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0012 affected35 at risk
Depression	Psychiatric disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Proteinuria	Renal and urinary disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0015 affected35 at risk
Metrorrhagia	Reproductive system and breast disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Acne	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Dermatitis	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0000 affected36 at risk EG0012 affected35 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	17.0	Systematic Assessment	EG0002 affected36 at risk EG0010 affected35 at risk
Hypertension	Vascular disorders	17.0	Systematic Assessment	EG0001 affected36 at risk EG0015 affected35 at risk

ID	Term
D006332	Cardiomegaly
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006984	Hypertrophy
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids

ID	Term
D000068338	Everolimus
D016559	Tacrolimus
D009173	Mycophenolic Acid