Liver Spare the Nephron (STN) Study - A Study of CellCept... | NCT00118742

Status Module

Label	Type	Description	Intervention Names
CellCept + CNI (tacrolimus or cyclosporine)	Experimental		Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine
CellCept + sirolimus	Active Comparator		Drug: mycophenolate mofetil [CellCept] Drug: Sirolimus

Name	Type	Description	Arm Group Labels	Other Names
mycophenolate mofetil [CellCept]	Drug	1-1.5 g orally or intravenously twice daily	CellCept + CNI (tacrolimus or cyclosporine) CellCept + sirolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant	Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.	12 months posttransplant

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant	Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.	6 months posttransplant

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
FG001	CellCept + Sirolimus

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant

Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

intent-to-treat population

Posted

Mean

Standard Deviation

Percent change in GFR (mL/min)

12 months posttransplant

ID	Title	Description
OG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
OG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Units	Counts
Participants	OG000124 OG001130

Title

Denominators

Categories

Title	Measurements
	OG0001.2± 39.86 OG00119.7± 40.64

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.0012		Mean Difference (Final Values)	24.9				95	14.8	35.0				No	Superiority or Other

Secondary

Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant

Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

intent-to-treat population

Posted

Mean

Standard Deviation

Percent change in GFR (mL/min)

6 months posttransplant

ID	Title	Description
OG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
OG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant

intent-to-treat population

Posted

Mean

Standard Deviation

Mean percent change in GFR (mL/min)

24 months posttransplant

ID	Title	Description
OG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
OG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Creatinine Clearance

Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation

intent-to-treat population

Posted

Mean

Standard Deviation

Percent change in creatinine CL (mL/min)

6, 12, and 24 months posttransplantation

ID	Title	Description
OG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
OG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Statistical Information
Hepatitis C	Infections and infestations	EG00010 affected146 at risk EG0018 affected148 at risk
Pneumonia	Infections and infestations	EG0003 affected146 at risk EG0012 affected148 at risk
Sepsis	Infections and infestations	EG0003 affected146 at risk EG0012 affected148 at risk
Clostridium Difficile Colitis	Infections and infestations	EG0001 affected146 at risk EG0013 affected148 at risk
Viral Infection	Infections and infestations	EG0001 affected146 at risk EG0011 affected148 at risk
Abdominal Wall Infection	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Acarodermatitis	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Appendicitis	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Bacteraemia	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Cellulitis	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Clostridial Infection	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Diverticulitis	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Escherichia Urinary Tract Infection	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Influenza	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Lactobacillus Infection	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Liver Abscess	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Lobar Pneumonia	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Pseudomonal Sepsis	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Respiratory Tract Infection	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Sinusitis	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Staphylococcal Infection	Infections and infestations	EG0001 affected146 at risk EG0010 affected148 at risk
Subcutaneous Abscess	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Urinary Tract Infection	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Wound Infection	Infections and infestations	EG0000 affected146 at risk EG0011 affected148 at risk
Diarrhoea	Gastrointestinal disorders	EG0002 affected146 at risk EG0013 affected148 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG0000 affected146 at risk EG0012 affected148 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	EG0002 affected146 at risk EG0010 affected148 at risk
Mouth Ulceration	Gastrointestinal disorders	EG0000 affected146 at risk EG0012 affected148 at risk
Peritonitis	Gastrointestinal disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Umbilical Hernia	Gastrointestinal disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Abdominal Hernia	Gastrointestinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Colitis	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Crohn's Disease	Gastrointestinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Duodenitis Haemorrhagic	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Gastritis	Gastrointestinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Ileus	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Inguinal Hernia	Gastrointestinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Inguinal Hernia, Obstructive	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Pancreatitis	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Rectal Ulcer Haemorrhage	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Incisional Hernia	Injury, poisoning and procedural complications	EG0004 affected146 at risk EG0014 affected148 at risk
Anastomotic Stenosis	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0012 affected148 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	EG0001 affected146 at risk EG0011 affected148 at risk
Procedural Pain	Injury, poisoning and procedural complications	EG0001 affected146 at risk EG0011 affected148 at risk
Biliary Anastomosis Complication	Injury, poisoning and procedural complications	EG0001 affected146 at risk EG0010 affected148 at risk
Complications of Transplanted Kidney	Injury, poisoning and procedural complications	EG0001 affected146 at risk EG0010 affected148 at risk
Foot Fracture	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Graft Loss	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Rib Fracture	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Stress Fracture	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	EG0000 affected146 at risk EG0011 affected148 at risk
Cholangitis	Hepatobiliary disorders	EG0000 affected146 at risk EG0014 affected148 at risk
Bile Duct Obstruction	Hepatobiliary disorders	EG0002 affected146 at risk EG0010 affected148 at risk
Bile Duct Stenosis	Hepatobiliary disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Biliary Tract Disorder	Hepatobiliary disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Hepatic Artery Thrombosis	Hepatobiliary disorders	EG0000 affected146 at risk EG0012 affected148 at risk
Autoimmune Hepatitis	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Cholestasis	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Haemobilia	Hepatobiliary disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Hepatic Artery Stenosis	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hepatic Failure	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hepatic Function Abnormal	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hepatic Infarction	Hepatobiliary disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Hepatitis Acute	Hepatobiliary disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Perforation Bile Duct	Hepatobiliary disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Portal Vein Thrombosis	Hepatobiliary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Pyrexia	General disorders	EG0001 affected146 at risk EG0017 affected148 at risk
Chest Pain	General disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Multi-Organ Failure	General disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Fat Tissue Increased	General disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Fatigue	General disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hernia	General disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Hernia Obstructive	General disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Impaired Healing	General disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Malaise	General disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Ulcer Haemorrhage	General disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Hepatic Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 affected146 at risk EG0013 affected148 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Desmoid Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Epstein-Barr Virus Associated Lymphoproliferative Disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Gastrointestinal Tract Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Hepatic Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Non-Small Cell Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected146 at risk EG0010 affected148 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected146 at risk EG0011 affected148 at risk
Anaemia	Blood and lymphatic system disorders	EG0001 affected146 at risk EG0014 affected148 at risk
Leukopenia	Blood and lymphatic system disorders	EG0002 affected146 at risk EG0011 affected148 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Neutropenia	Blood and lymphatic system disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	EG0004 affected146 at risk EG0010 affected148 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Alveolitis Allergic	Respiratory, thoracic and mediastinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Deep Vein Thrombosis	Vascular disorders	EG0002 affected146 at risk EG0014 affected148 at risk
Embolism Venous	Vascular disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hypertension	Vascular disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Orthostatic Hypotension	Vascular disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Vasculitis	Vascular disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG0004 affected146 at risk EG0010 affected148 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0002 affected146 at risk EG0010 affected148 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hyponatraemia	Metabolism and nutrition disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Headache	Nervous system disorders	EG0002 affected146 at risk EG0011 affected148 at risk
Cerebral Haemorrhage	Nervous system disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Convulsion	Nervous system disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Encephalopathy	Nervous system disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Haemorrhage Intracranial	Nervous system disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Neuralgic Amyotrophy	Nervous system disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Neuroleptic Malignant Syndrome	Nervous system disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Atrial Fibrillation	Cardiac disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Cardiac Failure Congestive	Cardiac disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Myocardial Infarction	Cardiac disorders	EG0000 affected146 at risk EG0012 affected148 at risk
Acute Myocardial Infarction	Cardiac disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Atrial Flutter	Cardiac disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Cardiac Arrest	Cardiac disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Mitral Valve Incompetence	Cardiac disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Ventricular Tachycardia	Cardiac disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Renal Failure	Renal and urinary disorders	EG0005 affected146 at risk EG0010 affected148 at risk
Renal Failure Acute	Renal and urinary disorders	EG0002 affected146 at risk EG0010 affected148 at risk
Urinary Retention	Renal and urinary disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hepatic Enzyme Increased	Investigations	EG0000 affected146 at risk EG0012 affected148 at risk
Blood Alkaline Phosphatase Increased	Investigations	EG0001 affected146 at risk EG0010 affected148 at risk
Blood Creatinine Increased	Investigations	EG0001 affected146 at risk EG0010 affected148 at risk
Blood Glucose Increased	Investigations	EG0001 affected146 at risk EG0010 affected148 at risk
Liver Function Test Abnormal	Investigations	EG0001 affected146 at risk EG0010 affected148 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG0002 affected146 at risk EG0010 affected148 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Transplant Rejection	Immune system disorders	EG0001 affected146 at risk EG0011 affected148 at risk
Graft Versus Host Disease	Immune system disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Hypersensitivity	Immune system disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Liver Transplant Rejection	Immune system disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Ovarian Cyst	Reproductive system and breast disorders	EG0000 affected146 at risk EG0012 affected148 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Alcohol Abuse	Psychiatric disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Confusional State	Psychiatric disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Rash	Skin and subcutaneous tissue disorders	EG0000 affected146 at risk EG0011 affected148 at risk
Inappropriate Antidiuretic Hormone Secretion	Endocrine disorders	EG0001 affected146 at risk EG0010 affected148 at risk
Cataract	Eye disorders	EG0000 affected146 at risk EG0011 affected148 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Diarrhoea	Gastrointestinal disorders	EG00042 affected146 at risk EG00137 affected148 at risk
Abdominal Pain	Gastrointestinal disorders	EG00026 affected146 at risk EG00121 affected148 at risk
Nausea	Gastrointestinal disorders	EG00023 affected146 at risk EG00119 affected148 at risk
Vomiting	Gastrointestinal disorders	EG00020 affected146 at risk EG00112 affected148 at risk
Abdominal Pain Upper	Gastrointestinal disorders	EG00011 affected146 at risk EG0017 affected148 at risk
Constipation	Gastrointestinal disorders	EG00010 affected146 at risk EG0016 affected148 at risk
Mouth Ulceration	Gastrointestinal disorders	EG0000 affected146 at risk EG00110 affected148 at risk
Stomatitis	Gastrointestinal disorders	EG0001 affected146 at risk EG0019 affected148 at risk
Hepatitis C	Infections and infestations	EG00023 affected146 at risk EG00120 affected148 at risk
Upper Respiratory Tract Infection	Infections and infestations	EG0008 affected146 at risk EG0017 affected148 at risk
Sinusitis	Infections and infestations	EG00010 affected146 at risk EG0014 affected148 at risk
Nasopharyngitis	Infections and infestations	EG0007 affected146 at risk EG0015 affected148 at risk
Pyrexia	General disorders	EG00021 affected146 at risk EG00125 affected148 at risk
Fatigue	General disorders	EG00023 affected146 at risk EG00126 affected148 at risk
Oedema Peripheral	General disorders	EG00017 affected146 at risk EG00127 affected148 at risk
Asthenia	General disorders	EG0007 affected146 at risk EG0018 affected148 at risk
Headache	Nervous system disorders	EG00024 affected146 at risk EG00138 affected148 at risk
Tremor	Nervous system disorders	EG00015 affected146 at risk EG00112 affected148 at risk
Dizziness	Nervous system disorders	EG00011 affected146 at risk EG0018 affected148 at risk
Rash	Skin and subcutaneous tissue disorders	EG0005 affected146 at risk EG00126 affected148 at risk
Pruritis	Skin and subcutaneous tissue disorders	EG00013 affected146 at risk EG0018 affected148 at risk
Night Sweats	Skin and subcutaneous tissue disorders	EG0006 affected146 at risk EG00111 affected148 at risk
Acne	Skin and subcutaneous tissue disorders	EG0004 affected146 at risk EG0017 affected148 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00013 affected146 at risk EG00114 affected148 at risk
Back Pain	Musculoskeletal and connective tissue disorders	EG00015 affected146 at risk EG00111 affected148 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	EG00012 affected146 at risk EG0019 affected148 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0007 affected146 at risk EG0017 affected148 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0004 affected146 at risk EG0018 affected148 at risk
Hepatic Enzyme Increased	Investigations	EG00011 affected146 at risk EG00112 affected148 at risk
Liver Function Test Abnormal	Investigations	EG0009 affected146 at risk EG00112 affected148 at risk
Weight Increased	Investigations	EG0008 affected146 at risk EG0019 affected148 at risk
Weight Decreased	Investigations	EG00010 affected146 at risk EG0015 affected148 at risk
White Blood Cell Count Decreased	Investigations	EG0009 affected146 at risk EG0015 affected148 at risk
Blood Creatinine Increased	Investigations	EG0009 affected146 at risk EG0010 affected148 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	EG0005 affected146 at risk EG00115 affected148 at risk
Hyperkalaemia	Metabolism and nutrition disorders	EG00014 affected146 at risk EG0012 affected148 at risk
Anorexia	Metabolism and nutrition disorders	EG0006 affected146 at risk EG0018 affected148 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	EG0002 affected146 at risk EG00110 affected148 at risk
Decreased Appetite	Metabolism and nutrition disorders	EG0008 affected146 at risk EG0013 affected148 at risk
Hypokalaemia	Metabolism and nutrition disorders	EG0003 affected146 at risk EG0017 affected148 at risk
Leukopenia	Blood and lymphatic system disorders	EG00021 affected146 at risk EG00135 affected148 at risk
Anaemia	Blood and lymphatic system disorders	EG00014 affected146 at risk EG00113 affected148 at risk
Neutropenia	Blood and lymphatic system disorders	EG00011 affected146 at risk EG0017 affected148 at risk
Thrombocytopenia	Blood and lymphatic system disorders	EG0005 affected146 at risk EG0017 affected148 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00013 affected146 at risk EG00113 affected148 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00010 affected146 at risk EG0019 affected148 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	EG0006 affected146 at risk EG00111 affected148 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	EG0006 affected146 at risk EG0017 affected148 at risk
Incisional Hernia	Injury, poisoning and procedural complications	EG0003 affected146 at risk EG0019 affected148 at risk
Incision Site Pain	Injury, poisoning and procedural complications	EG0007 affected146 at risk EG0018 affected148 at risk
Insomnia	Psychiatric disorders	EG00016 affected146 at risk EG00113 affected148 at risk
Depression	Psychiatric disorders	EG0008 affected146 at risk EG00110 affected148 at risk
Hypertension	Vascular disorders	EG00015 affected146 at risk EG00116 affected148 at risk
Renal Failure	Renal and urinary disorders	EG0007 affected146 at risk EG0012 affected148 at risk
Jaundice	Hepatobiliary disorders	EG0007 affected146 at risk EG0012 affected148 at risk

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

ID	Title	Description
BG000	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
BG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
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	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months			65	146	134	146
EG001	CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months			67	148	141	148

ID	Term
D009173	Mycophenolic Acid
D016559	Tacrolimus
D016572	Cyclosporine
D020123	Sirolimus