Efficacy and Safety of Everolimus in Combination With Cyc... | NCT00425308

Label	Type	Description	Intervention Names
Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)	Active Comparator	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids	Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) Drug: Steroids
Everolimus + Cyclosporine	Active Comparator	Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids	Drug: Everolimus + Cyclosporine Drug: Steroids

Name	Type	Description	Arm Group Labels	Other Names
Everolimus + Cyclosporine	Drug		Everolimus + Cyclosporine	Cyclosporine Microemulsion Neoral

Measure	Description	Time Frame
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.	Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)	From Baseline to Month 12
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial	Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)	From Baseline to Month 12

Measure	Description	Time Frame
Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12		From Baseline to Month 3, 6, and 12
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.		Month 6 and 12

Name	Affiliation	Role
Novartis	Novartis	Study Director

ID	Title	Description
FG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
FG001

ID	Title	Description
BG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
BG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00015 BG00115 BG00230

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 in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.

Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

Intent to Treat (ITT) Population: all patients with a baseline value

Posted

Least Squares Mean

Standard Error

(mL/min)

From Baseline to Month 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG00013 OG00114

Title

Denominators

Categories

Title	Measurements
	OG000-4.07± 5.03 OG00110.30± 4.84

Primary

Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial

Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

Intent to Treat (ITT) Population: completed patients

Posted

Least Squares Mean

Standard Error

(mL/min)

From Baseline to Month 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants

Secondary

Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12

Intent to Treat Population

Posted

Mean

Standard Deviation

µmol/L

From Baseline to Month 3, 6, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.

Intent to Treat Population

Posted

Number

participants

Month 6 and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12.

Intent to Treat (ITT) Population

Posted

Number

participants

Month 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12

Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12

Intent to Treat Population

Posted

Mean

Standard Deviation

mL/min/1.73m²

From Baseline to Month 3, 6, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants

Secondary

Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12

Change in proteinuria (g/24h) from baseline to M12

Intent to Treat Population

Posted

Mean

Standard Deviation

g/24h

From Baseline to Month 3, 6, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Assessing Cardiovascular Risk Factors Based on Fasting Glucose.

Blood chemistry - fasting glycemia (mmol/L)

Safety population

Posted

Mean

Standard Deviation

mmol/L

From Baseline to Month 1, 3, 6, 9, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.

Blood chemistry - total cholesterol (mmol/L)

Safety population

Posted

Mean

Standard Deviation

mmol/L

From Baseline to Month 1, 3, 6, 9, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.

Safety population

Posted

Mean

Standard Deviation

mmol/L

From Baseline to Month 3, 6, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.

Safety population

Posted

Mean

Standard Deviation

mmol/L

From Baseline to Month 1, 3, 6, 9, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Secondary

Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).

Blood chemistry - C-reactive Protein (CRP) (mg/L)

Safety population

Posted

Mean

Standard Deviation

mg/L

From Baseline to Month 3, 6, and 12

ID	Title	Description
OG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
OG001	Enteric-coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0012 affected15 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0012 affected15 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Kidney transplant rejection	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Herpes zoster ophthalmic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected15 at risk EG0010 affected15 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0012 affected15 at risk
C-reactive protein increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Prostatic specific antigen increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0012 affected15 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0015 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected15 at risk EG0011 affected15 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Gingival hypertrophy	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0004 affected15 at risk EG0014 affected15 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Cholestasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Alveolar osteitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected15 at risk EG0011 affected15 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Nasal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Renal cyst infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0010 affected15 at risk
Chronic allograft nephropathy	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0012 affected15 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Cerebral venous thrombosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0010 affected15 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected15 at risk EG0010 affected15 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0010 affected15 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D000072473	Fused-Ring Compounds

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cyclosporine	Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids			8	15	11	15
EG001	Enteric-Coated Mycophenolate Sodium (EC-MPS)	Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids			10	15	14	15

ID	Term
D000068338	Everolimus
D016572	Cyclosporine
D009173	Mycophenolic Acid
D013256	Steroids