Kidney Spare the Nephron (STN) Study - A Study of CellCep... | NCT00121810

Label	Type	Description	Intervention Names
1	Experimental		Drug: mycophenolate mofetil [CellCept] Drug: Corticosteroids Drug: Sirolimus
2	Active Comparator		Drug: mycophenolate mofetil [CellCept] Drug: Corticosteroids Drug: Calcineurin inhibitors

Name	Type	Description	Arm Group Labels	Other Names
mycophenolate mofetil [CellCept]	Drug	1.0-1.5 g oral dose twice daily	1 2

Measure	Description	Time Frame
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12	The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.	baseline to 12 months

Measure	Description	Time Frame
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24	A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Bakersfield	California	93309	United States

ID	Title	Description
FG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
FG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus

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

Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12

The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.

percent change= [(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.

Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 12: MMF+sirolimus = 120, MMF+CNI = 111.

Posted

Mean

Standard Deviation

percent change

baseline to 12 months

ID	Title	Description
OG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
OG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Units	Counts
Participants	OG000148 OG001151

Title

Denominators

Categories

Baseline

Title	Measurements
	OG00059.5± 23.86 OG00158.8± 26.06

Mean Percent Change from Baseline at Month 12

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary analysis tested the null hypothesis that mean percent change from baseline to 12 months for Group 1 (mycophenolate mofetil + sirolimus) was equal to that for Group 2 (mycophenolate mofetil + cyclosporine or tacrolimus) based on the intent-to-treat population.	ANCOVA		0.012	P value comparing the treatment groups calculated using ANCOVA model treatment and baseline calcineurin inhibitor (cyclosporine or tacrolimus) as factors and baseline measurement and time from transplant to randomization as covariates.	Median Difference (Net)	18.7				95	4.2	33.2				No	Superiority or Other

Secondary

Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24

A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.

percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.

Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 24: MMF+sirolimus = 115, MMF+CNI = 105.

Posted

Mean

Standard Deviation

percent change

Baseline to 24 months

ID	Title	Description
OG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
OG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Units	Counts

Secondary

Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.

percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.

Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Posted

Mean

Standard Deviation

percent change

baseline, 6, 12, and 24 months

ID	Title	Description
OG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
OG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Secondary

Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.

percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization

Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 129; AP at Month 12: MMF+sirolimus = 124, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Posted

Mean

Standard Deviation

percent change

baseline 6, 12, and 24 months

ID	Title	Description
OG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
OG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Secondary

Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)

Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.

percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.

Intent-to-treat population. Analysis population (AP) at Baseline: Mycophenolate mofetil (MMF) + sirolimus = 148, MMF + cyclosporine or tacrolimus (CNI) = 151; AP at Month 6: MMF+sirolimus = 117, MMF+CNI = 130; AP at Month 12: MMF+sirolimus = 123, MMF+CNI = 123; AP at Month 24: MMF+sirolimus = 120, MMF+CNI = 116.

Posted

Mean

Standard Deviation

percent change

baseline, 6, 12, and 24 months

ID	Title	Description
OG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
OG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00014 affected148 at risk EG0019 affected153 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0005 affected148 at risk EG0018 affected153 at risk
Pyelonephritis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected148 at risk EG0013 affected153 at risk
Cellulitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected148 at risk EG0011 affected153 at risk
Urosepsis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected148 at risk EG0012 affected153 at risk
Gastroenteritis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Gangrene	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0010 affected153 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Osteomyelitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Sepsis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Viral Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Appendicitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Bacteraemia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Bacterial Diarrhoea	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
BK Virus Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Bronchitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Catheter Related Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Coccidioidomycosis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Diarrhoea Infectious	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Ear Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Epstein-Barr Virus Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Gastroenteritis Clostridial	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Infected Skin Ulcer	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Liver Abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Lung Abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Nocardiosis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Perinephric Abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Pharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Sinusitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Staphylococcal Abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Wound Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Chest Pain	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected148 at risk EG0013 affected153 at risk
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected148 at risk EG0013 affected153 at risk
Asthenia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Chest Discomfort	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Hyperthermia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Impaired Healing	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Oedema Peripheral	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected148 at risk EG0013 affected153 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0012 affected153 at risk
Bowen's Disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Anal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0013 affected153 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0012 affected153 at risk
Gastritis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0010 affected153 at risk
Diabetic Gastroparesis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Ileus Paralytic	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Mouth Haemorrhage	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Retroperitoneal Haematoma	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Focal Segmental Glomerulosclerosis	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Renal Failure	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Urinary Tract Disorder	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0010 affected153 at risk
Urinary Tract Obstruction	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected148 at risk EG0011 affected153 at risk
Hypertensive Emergency	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Thrombophlebitis	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Venous Stenosis	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0011 affected153 at risk
Angina Unstable	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Pericarditis	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Supraventricular Tachyarrhythmia	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Tachycardia	Cardiac disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Blood Creatinine Increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0013 affected153 at risk
Blood Glucose Increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Post Procedural Haematuria	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Spinal Fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Hungry Bone Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Neuropathic Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0012 affected153 at risk
Brain Stem Infarction	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Cervical Cord Compression	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Intracranial Aneurysm	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Haemolytic Uraemic Syndrome	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Thrombocytopenic Purpura	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Obstructive Airways Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0010 affected153 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Neuropathic Ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0011 affected153 at risk
Serum Sickness	Immune system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0010 affected153 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Breast Oedema	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Normal Newborn	Pregnancy, puerperium and perinatal conditions	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Staphylococcal Bacteraemia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Cryptosporidiosis Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Groin Abscess	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Benign Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Acute Prerenal Failure	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Cervical Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0011 affected153 at risk
Open Reduction of Fracture	Surgical and medical procedures	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG0010 affected153 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary Tract Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00022 affected148 at risk EG00133 affected153 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00021 affected148 at risk EG00119 affected153 at risk
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00013 affected148 at risk EG00116 affected153 at risk
Pneumonia	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG00014 affected148 at risk EG00112 affected153 at risk
BK Virus Infection	Infections and infestations	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0019 affected153 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00051 affected148 at risk EG00150 affected153 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00017 affected148 at risk EG00110 affected153 at risk
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00014 affected148 at risk EG00112 affected153 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0009 affected148 at risk EG00114 affected153 at risk
Mouth Ulceration	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00021 affected148 at risk EG0010 affected153 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0000 affected148 at risk EG0018 affected153 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG00044 affected148 at risk EG00120 affected153 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG00020 affected148 at risk EG0016 affected153 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0019 affected153 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0009 affected148 at risk EG0016 affected153 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0019 affected153 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0013 affected153 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Non-systematic Assessment	EG0003 affected148 at risk EG0018 affected153 at risk
Oedema Peripheral	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00042 affected148 at risk EG00120 affected153 at risk
Fatigue	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00015 affected148 at risk EG00112 affected153 at risk
Pyrexia	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00015 affected148 at risk EG00112 affected153 at risk
Oedema	General disorders	MedDRA (12.0)	Non-systematic Assessment	EG00010 affected148 at risk EG0015 affected153 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00011 affected148 at risk EG00111 affected153 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00015 affected148 at risk EG0016 affected153 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00012 affected148 at risk EG0019 affected153 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0017 affected153 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0004 affected148 at risk EG0018 affected153 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0009 affected148 at risk EG0012 affected153 at risk
Blood Creatinine Increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG00014 affected148 at risk EG00131 affected153 at risk
Weight Increased	Investigations	MedDRA (12.0)	Non-systematic Assessment	EG0007 affected148 at risk EG0018 affected153 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG00036 affected148 at risk EG00129 affected153 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG00025 affected148 at risk EG00117 affected153 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0019 affected153 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0002 affected148 at risk EG0017 affected153 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG00012 affected148 at risk EG0017 affected153 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0017 affected153 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0013 affected153 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG00016 affected148 at risk EG00116 affected153 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0017 affected153 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0007 affected148 at risk EG0014 affected153 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Non-systematic Assessment	EG0009 affected148 at risk EG0010 affected153 at risk
Headache	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG00011 affected148 at risk EG00110 affected153 at risk
Dizziness	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0018 affected153 at risk
Tremor	Nervous system disorders	MedDRA (12.0)	Non-systematic Assessment	EG0001 affected148 at risk EG00114 affected153 at risk
Hypertension	Vascular disorders	MedDRA (12.0)	Non-systematic Assessment	EG00030 affected148 at risk EG00125 affected153 at risk
Proteinuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG00018 affected148 at risk EG0016 affected153 at risk
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Non-systematic Assessment	EG0007 affected148 at risk EG0012 affected153 at risk
Insomnia	Psychiatric disorders	MedDRA (12.0)	Non-systematic Assessment	EG0008 affected148 at risk EG0017 affected153 at risk

ID	Term
D009173	Mycophenolic Acid
D000305	Adrenal Cortex Hormones
D065095	Calcineurin Inhibitors
D020123	Sirolimus

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D018942	Macrolides
D007783	Lactones

ID	Title	Description
BG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
BG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Mycophenolate Mofetil + Sirolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily			60	148	147	148
EG001	Mycophenolate Mofetil + Cyclosporine or Tacrolimus	Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol			64	153	148	153