A Study Investigating the Renal Tolerability, Efficacy, a... | NCT00862979

ID	Type	Description	Link
2007-002671-14

Label	Type	Description	Intervention Names
CNI-regimen	Active Comparator	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids	Drug: Everolimus (EVR) Drug: cyclosporine A (CyA) Drug: tacrolimus (TAC) Drug: Corticosteroids
CNI-free-regimen	Experimental	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids	Drug: Everolimus (EVR) Drug: cyclosporine A (CyA) Drug: tacrolimus (TAC) Drug: Enteric coated mycophenolate sodium (EC-MPS) Drug: mycophenolate mofetil (MMF) Drug: Corticosteroids

Name	Type	Description	Arm Group Labels	Other Names
Everolimus (EVR)	Drug	Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)	CNI-free-regimen CNI-regimen

Measure	Description	Time Frame
Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18	Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3(C-1.154)(A-0.203)GR where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.	Month 18

Measure	Description	Time Frame
Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18	Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Heart transplantation, 3 months prior to enrollment
Patients have to receive an immunosuppressive regimen with Sandimmun® Optoral, Certican® and corticosteroids
Sufficient graft function
Sufficient renal function
Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility

Exclusion criteria:

Multi-organ recipients, re-transplantation, or previous transplant with any other organ.
Patients who are recipients of A-B-O incompatible transplants
Cold ischemia time >6 hours
Historical or current peak PRA of > 25% at time of transplantation
Already existing antibodies against the HLA-type of the receiving transplant Other protocol-defined inclusion/exclusion criteria may apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Bad Oeynhausen		32545	Germany
Novartis Investigative Site

ID	Title	Description
FG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
FG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 19, 2016	Mar 5, 2018

ID	Title	Description
BG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
BG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00074 BG00171 BG002145

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

Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18

Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 18 cGFR (in mL/min/1.73 m2) = 186.3*(C-1.154)*(A-0.203)*G*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.

Full Analysis Set-Last observation carried forward (FAS-LOCF)- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable but for this analysis only participants that had values at Month 18 were analyzed

Posted

Mean

Standard Deviation

mL/min

Month 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants	OG00069 OG00165

Title

Denominators

Categories

Title	Measurements
	OG00054.2± 17.9 OG00166.9± 23.0

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		<.0001		Mean Difference (Net)	-11.3			2-Sided	95	-16.5	-6.1					Superiority

Secondary

Occurrence of Treatment Failures From Month 6 to 9 and Month 9 to 18

Treatment failure was defined as composite endpoint of biopsy proven acute rejection of ISHLT 1990 grade ≥ 3A resp. ISHLT 2004 grade ≥ 2R, acute rejection episodes associated with hemodynamic compromise, graft loss / re-transplant, death, loss to follow up (at least one condition must be present). If participant had an occurrence in each period it was counted for each period.

Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable

Posted

Number

Occurences

Month 6 to Month 9; Month 9 to Month 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants

Secondary

Occurrence of Major Cardiac Events (MACE) From Month 6 to 18

Major cardiac events (MACE) was defined as one of the following: any death, myocardial infarction, coronary artery bypass grafting

Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable

Posted

Number

Occurences

Month 6 to Month 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants	OG000

Secondary

Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 12 and 18

Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 12 and 18. For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)

Posted

Mean

Standard Deviation

mL/min

Month 12 and 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants

Secondary

Serum Creatinine at Month 6, 8, 9, 10 12 and 18

Serum Creatinine is an indicator of renal function measured in the blood

Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable

Posted

Mean

Standard Deviation

μmol/L

Month 6, 8, 9, 10 12 and 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants	OG000

Secondary

Reciprocal Creatinine Slope Between Month 6 and Month 18

Reciprocal Creatinine Slope is an indication of renal function over time with a higher slope value indicating an improvement in renal function.

Full Analysis Set FAS- 145 patients were treated with study medication and had at least 1 post-baseline assessment of the primary outcome variable

Posted

Mean

Standard Deviation

1/(μmol/L)/(hour)

Between Month 6 and Month 18

ID	Title	Description
OG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids
OG001	CNI-free-regimen	CNI-free regimen: everolimus (EVR) with MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and corticosteroids

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0013 affected78 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0011 affected78 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0011 affected78 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
EYE PAIN	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
GLAUCOMA	Eye disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0012 affected78 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
VOMITING	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0011 affected78 at risk
CHEST PAIN	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CHILLS	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
FATIGUE	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
OEDEMA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
PYREXIA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0012 affected78 at risk
STENOSIS	General disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
HEART TRANSPLANT REJECTION	Immune system disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0017 affected78 at risk
ANAL ABSCESS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
ASPERGILLOMA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
ASPERGILLUS INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
BACTERAEMIA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CAMPYLOBACTER GASTROENTERITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
DIABETIC GANGRENE	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
DIVERTICULITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
ENDOCARDITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
ESCHERICHIA INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
FEBRILE INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
GASTROENTERITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0012 affected78 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
GASTROENTERITIS SALMONELLA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
GROIN INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
H1N1 INFLUENZA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
HERPES ZOSTER	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0011 affected78 at risk
HERPES ZOSTER INFECTION NEUROLOGICAL	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
INFECTED LYMPHOCELE	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0011 affected78 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
INFLUENZA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
PNEUMOCYSTIS JIROVECII PNEUMONIA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
PNEUMONIA	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0006 affected84 at risk EG0012 affected78 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
TUBERCULOSIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
URETERITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
WOUND INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
ACETABULUM FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
INFLAMMATORY MARKER INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
WEIGHT INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
PLASMACYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
PROSTATE CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
MYOCLONIC EPILEPSY	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
SCIATICA	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
SYNCOPE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0011 affected78 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0011 affected78 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0010 affected78 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0012 affected78 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
PULMONARY MASS	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
SKIN HAEMORRHAGE	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
MEDICAL DEVICE REMOVAL	Surgical and medical procedures	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
ANEURYSM	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0000 affected84 at risk EG0011 affected78 at risk
ANGIOPATHY	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0010 affected78 at risk
HYPERTENSION	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0010 affected78 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected84 at risk EG0017 affected78 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA (20.0)	Systematic Assessment	EG00010 affected84 at risk EG00110 affected78 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0015 affected78 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (20.0)	Systematic Assessment	EG0008 affected84 at risk EG0017 affected78 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected84 at risk EG0014 affected78 at risk
APHTHOUS ULCER	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected84 at risk EG0015 affected78 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG00011 affected84 at risk EG0015 affected78 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG00010 affected84 at risk EG0016 affected78 at risk
VOMITING	Gastrointestinal disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0012 affected78 at risk
FATIGUE	General disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0014 affected78 at risk
OEDEMA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0012 affected78 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (20.0)	Systematic Assessment	EG00017 affected84 at risk EG00120 affected78 at risk
PYREXIA	General disorders	MedDRA (20.0)	Systematic Assessment	EG0008 affected84 at risk EG0015 affected78 at risk
BRONCHITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0008 affected84 at risk EG0013 affected78 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00011 affected84 at risk EG0014 affected78 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG00023 affected84 at risk EG00112 affected78 at risk
ORAL HERPES	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0015 affected78 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (20.0)	Systematic Assessment	EG0001 affected84 at risk EG0014 affected78 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0011 affected78 at risk
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0013 affected78 at risk
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected84 at risk EG0013 affected78 at risk
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0009 affected84 at risk EG0015 affected78 at risk
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0008 affected84 at risk EG0016 affected78 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0012 affected78 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected84 at risk EG00113 affected78 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0007 affected84 at risk EG0011 affected78 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0006 affected84 at risk EG0011 affected78 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0002 affected84 at risk EG0015 affected78 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0011 affected78 at risk
HEADACHE	Nervous system disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0017 affected78 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0004 affected84 at risk EG0015 affected78 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (20.0)	Systematic Assessment	EG0008 affected84 at risk EG0015 affected78 at risk
ACNE	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0003 affected84 at risk EG0016 affected78 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA (20.0)	Systematic Assessment	EG0005 affected84 at risk EG0012 affected78 at risk
HYPERTENSION	Vascular disorders	MedDRA (20.0)	Systematic Assessment	EG0009 affected84 at risk EG0013 affected78 at risk

ID	Term
D000068338	Everolimus
D016572	Cyclosporine
D016559	Tacrolimus
D009173	Mycophenolic Acid
D000305	Adrenal Cortex Hormones

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
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CNI-regimen	CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids	0	84	40	84	74	84
EG001	CNI-free-regimen	CNI-free regimen: MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and everolimus and corticosteroids; On month 6 to 9 only: Cyclosporin A or tacrolimus	1	78	29	78	65	78