Non-inferiority Study of Safety and Efficacy of Everolimu... | NCT01025817

Label	Type	Description	Intervention Names
Everolimus (EVR) & low dose of tacrolimus	Experimental	Everolimus (EVR) and tacrolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.	Drug: Everolimus and tacrolimus
Mycophenolate mofetil & standard dose tacrolimus	Active Comparator	Mycophenolate mofetil and tacrolimus (MMF) treatment arm: MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. Tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, target level of tacrolimus was reduced to 5 - 8 ng/mL.	Drug: mycophenolate mofetil and tacrolimus

Name	Type	Description	Arm Group Labels	Other Names
Everolimus and tacrolimus	Drug	Everolimus: Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets Dose: 1.5 mg per day Frequency: 0.75 mg twice daily Tacrolimus: Dose adjusted to maintain specific blood levels

Measure	Description	Time Frame
Number of Participants With Incidence of Composite Efficacy Failure	Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR), (2) graft loss, (3) participant death or(4) loss to follow-up. A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.	12 Months

Measure	Description	Time Frame
Estimated Glomerular Filtration Rate (eGFR)	Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3(C˄-1.154)(A˄-0.203)GR. DEFINITIONS: C = 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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Birmingham	Alabama	35233	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
28141897	Derived	Shihab F, Qazi Y, Mulgaonkar S, McCague K, Patel D, Peddi VR, Shaffer D. Association of Clinical Events With Everolimus Exposure in Kidney Transplant Patients Receiving Low Doses of Tacrolimus. Am J Transplant. 2017 Sep;17(9):2363-2371. doi: 10.1111/ajt.14215. Epub 2017 Mar 4.

ID	Title	Description
FG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.

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

Number of Participants With Incidence of Composite Efficacy Failure

Efficacy failure rate used the composite endpoint of: (1) treated biopsy-proven acute rejection (BPAR)*, (2) graft loss**, (3) participant death or(4) loss to follow-up. *A treated BPAR was defined as a biopsy graded IA, IB, IIA, IIB, or III and which was treated with anti-rejection therapy. **Graft loss is defined as when the allograft was presumed lost on the day the participant started dialysis and was not able to subsequently be removed from dialysis.

Full Analysis Set (FAS) consisted of all participants randomized after transplantation

Posted

Number

Participants

12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Units	Counts
Participants	OG000309 OG001304

Title

Denominators

Categories

Composite Endpoint

Title	Measurements
	OG00076 OG00162

Treated Biopsy-proven Acute rejection (BPAR)

Title	Measurements
	OG000

Secondary

Estimated Glomerular Filtration Rate (eGFR)

Renal function was assessed by estimated Glomerular Filtration Rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula. MDRD formula: GFR [mL/min/1.73m˄2] = 186.3*(C˄-1.154)*(A˄-0.203)*G*R. DEFINITIONS: C = 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 (FAS) consisted of all patients randomized after transplantation

Posted

Mean

Standard Deviation

mL/min/1.73m˄2

12 Months

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Secondary

Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)

Participants with incidence of CMV (viremia, syndrome and disease). CMV is cytomegalovirus.

Safety Set (SS) consisted of all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. The statement that a patient had no adverse events constitutes a safety assessment. Those who received at least 1 dose of drug but had no post-treatment safety data of any kind are excluded from SS.

Posted

Number

Participants

12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Secondary

Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy

Participants with Incidence of BKV (viremia, viruria, or nephropathy). BKV is Polyomavirus type BK.

Posted

Number

Participants

12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Secondary

Number of Participants With Incidence of New Onset of Diabetes Mellitus

Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant, or with a random plasma glucose ≥200 mg dL (11.1 mmol/L) with 2 fasting plasma glucose values ≥126 mg/dL (7 mmol/L)

Posted

Number

Participants

12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus

Secondary

Number of Participants With Incidence of Proteinuria Events

Number of participants with Incidence of proteinuria events indicating chronic kidney disease

Posted

Number

Participants

Baseline and 12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Secondary

Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events

Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events by System Organ Class

Posted

Number

Participants

12 Months

Participants

ID	Title	Description
OG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
OG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0014 affected304 at risk
Bandaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0013 affected304 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0014 affected304 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0013 affected304 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected306 at risk EG0010 affected304 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0012 affected304 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Congenital cystic kidney disease	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Congenital renal cyst	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0012 affected304 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG0018 affected304 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Internal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG0014 affected304 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Oral pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Tongue ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected306 at risk EG0017 affected304 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0015 affected304 at risk
Chills	General disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Hernia	General disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0010 affected304 at risk
Irritability	General disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Medical device complication	General disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0012 affected304 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00013 affected306 at risk EG00111 affected304 at risk
Rebound effect	General disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Sluggishness	General disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Kidney transplant rejection	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Transplant rejection	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Adenovirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
BK virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0014 affected304 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG0013 affected304 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Cerebral fungal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Clostridial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0013 affected304 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0015 affected304 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0012 affected304 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0012 affected304 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0013 affected304 at risk
Incision site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Mastitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Metapneumovirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected306 at risk EG0017 affected304 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Post procedural cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pulmonary mycosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG0014 affected304 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00022 affected306 at risk EG00124 affected304 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected306 at risk EG0017 affected304 at risk
Viraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected306 at risk EG0012 affected304 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected306 at risk EG0014 affected304 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Graft complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0009 affected306 at risk EG0018 affected304 at risk
Graft loss	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0013 affected304 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0011 affected304 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0011 affected304 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Renal haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0012 affected304 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Urinary anastomotic leak	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0011 affected304 at risk
Blood creatine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG00010 affected306 at risk EG00114 affected304 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Escherichia test positive	Investigations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Transaminases increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Urine output decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
White blood cell count increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG0015 affected304 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0017 affected304 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG0011 affected304 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0016 affected304 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0016 affected304 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0013 affected304 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Bone giant cell tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Pleural mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Dysarthria	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Encephalitis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Disorientation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0013 affected304 at risk
Psychotic disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Bladder spasm	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0015 affected304 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0016 affected304 at risk
Hydroureter	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal aneurysm	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0012 affected304 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal cyst ruptured	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0011 affected304 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG00116 affected304 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0010 affected304 at risk
Renal injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Renal pain	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0004 affected306 at risk EG0012 affected304 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0013 affected304 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0014 affected304 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0013 affected304 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Urinoma	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Vesicoureteric reflux	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected306 at risk EG0016 affected304 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0010 affected304 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0012 affected304 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected306 at risk EG0011 affected304 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG0010 affected304 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 affected306 at risk EG0010 affected304 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected306 at risk EG0011 affected304 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Pyelotomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Arteriovenous fistula	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0004 affected306 at risk EG0015 affected304 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Extrinsic iliac vein compression	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0011 affected304 at risk
Haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG0013 affected304 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0013 affected304 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Lymphocele	Vascular disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG0014 affected304 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected306 at risk EG0010 affected304 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected306 at risk EG0010 affected304 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk
Venous stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0012 affected304 at risk
Venous thrombosis limb	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected306 at risk EG0011 affected304 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00083 affected306 at risk EG00167 affected304 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00022 affected306 at risk EG00131 affected304 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00027 affected306 at risk EG00165 affected304 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 affected306 at risk EG00124 affected304 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00022 affected306 at risk EG00116 affected304 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00022 affected306 at risk EG00120 affected304 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00017 affected306 at risk EG00122 affected304 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00029 affected306 at risk EG00135 affected304 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000119 affected306 at risk EG001120 affected304 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00074 affected306 at risk EG001122 affected304 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 affected306 at risk EG00123 affected304 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 affected306 at risk EG00119 affected304 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00018 affected306 at risk EG00128 affected304 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000111 affected306 at risk EG001134 affected304 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00045 affected306 at risk EG00164 affected304 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00058 affected306 at risk EG00152 affected304 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG00032 affected306 at risk EG00128 affected304 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG000113 affected306 at risk EG00188 affected304 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG00041 affected306 at risk EG00147 affected304 at risk
BK virus infection	Infections and infestations	MedDRA	Systematic Assessment	EG00032 affected306 at risk EG00141 affected304 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 affected306 at risk EG00120 affected304 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00028 affected306 at risk EG00133 affected304 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00049 affected306 at risk EG00168 affected304 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00035 affected306 at risk EG00132 affected304 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00046 affected306 at risk EG00154 affected304 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00093 affected306 at risk EG00194 affected304 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG00049 affected306 at risk EG00141 affected304 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG00020 affected306 at risk EG00114 affected304 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG00123 affected304 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00017 affected306 at risk EG00118 affected304 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00032 affected306 at risk EG00130 affected304 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00021 affected306 at risk EG00123 affected304 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected306 at risk EG00117 affected304 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00075 affected306 at risk EG00181 affected304 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00093 affected306 at risk EG00181 affected304 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00071 affected306 at risk EG00131 affected304 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00023 affected306 at risk EG00125 affected304 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00046 affected306 at risk EG00140 affected304 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00020 affected306 at risk EG00123 affected304 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00056 affected306 at risk EG00154 affected304 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG000102 affected306 at risk EG001124 affected304 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00011 affected306 at risk EG00121 affected304 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG000108 affected306 at risk EG00194 affected304 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00035 affected306 at risk EG00139 affected304 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00021 affected306 at risk EG00125 affected304 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00031 affected306 at risk EG00123 affected304 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 affected306 at risk EG00123 affected304 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00015 affected306 at risk EG00120 affected304 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00028 affected306 at risk EG00124 affected304 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00026 affected306 at risk EG00136 affected304 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00044 affected306 at risk EG00153 affected304 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG00017 affected306 at risk EG0019 affected304 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG00051 affected306 at risk EG00186 affected304 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG00017 affected306 at risk EG00133 affected304 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00068 affected306 at risk EG00171 affected304 at risk
Dysuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00024 affected306 at risk EG00125 affected304 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00030 affected306 at risk EG00133 affected304 at risk
Proteinuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00031 affected306 at risk EG00119 affected304 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00020 affected306 at risk EG00119 affected304 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00017 affected306 at risk EG00113 affected304 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00028 affected306 at risk EG00143 affected304 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00040 affected306 at risk EG00149 affected304 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00023 affected306 at risk EG00124 affected304 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00020 affected306 at risk EG0017 affected304 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0006 affected306 at risk EG00118 affected304 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00032 affected306 at risk EG00132 affected304 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00024 affected306 at risk EG00112 affected304 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00064 affected306 at risk EG00171 affected304 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00025 affected306 at risk EG00129 affected304 at risk

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

ID	Title	Description
BG000	Everolimus and Low Dose Tacrolimus	Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
BG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
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	Everolimus and Low Dose Tacrolimus	Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.			154	306	302	306
EG001	Mycophenolate Mofetil and Standard Dose Tacrolimus	The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.			142	304	299	304

ID	Term
D000068338	Everolimus
D016559	Tacrolimus
D009173	Mycophenolic Acid