Preservation of Renal Function in Liver Transplant Recipi... | NCT00378014

ID	Type	Description	Link
2005-002920-32

Label	Type	Description	Intervention Names
Everolimus	Experimental	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice	Drug: basiliximab Drug: CNI
Calcineurin Inhibitor (CNI)	Active Comparator	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice	Drug: everolimus Drug: basiliximab Drug: CNI

Name	Type	Description	Arm Group Labels	Other Names
everolimus	Drug	Start dose of everolimus was 1.5 mg in the morning followed by 1.5 mg in the evening. After one week, the dose was adjusted to achieve trough levels between 5-12 ng/mL. Once trough levels were above 5ng/mL, the CNI dose was reduced to 70%. At week 8 post-baseline (latest at week 16 post baseline), CNI was completely discontinued. For patients receiving Ciclosporin A (CiA) as CNI, the everolimus dosage was adjusted to achieve a trough level of 8-12 ng/mL, prior to discontinuation of CiA. After discontinuation of CNI, everolimus was maintained at a trough level of 5-12 ng/mL.

Measure	Description	Time Frame
Calculated Glomerular Filtration Rate (cGFR)	This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.	Month 11

Measure	Description	Time Frame
Incidence of Efficacy Failure	Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).	Month 11

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Innsbruck		A-6020	Austria
Novartis Investigative Site

ID	Title	Description
FG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
FG001	Calcineurin Inhibitor (CNI)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Calculated Glomerular Filtration Rate (cGFR)

This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.

ITT

Posted

Mean

Standard Deviation

mL/min

Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG00096 OG00198

Title

Denominators

Categories

Title	Measurements
	OG00087.9± 32.0 OG00184.1± 34.9

Secondary

Incidence of Efficacy Failure

Efficacy failure was defined as the composite endpoint of biopsy-proven acute rejection (BPAR), graft loss, death, lost to follow-up (from any reason), whichever occurred first. Incidence of efficacy failure was estimated using crude rate estimation (relative frequency).

ITT

Posted

Number

Percentage of participants

Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Incidence of the Need for a Change in the Immunosuppressive Regimen

The incidence of any changes in the immunosuppressive regimen other than allowed in the study protocol (for example, introduction of Mycophenolic acid (MPA) or sirolimus) was estimated using crude rate estimation (relative frequency).

ITT

Posted

Number

Percentage of participants

Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Incidence of Renal Deterioration

Renal deterioration was defined as a decrease by ≥25% in the cGFR compared to baseline and confirmed by one consecutive measurement. The analysis of this outcome measure was omitted because of missing relevance.

Not Posted

Baseline, Month 11

Secondary

Renal Function (cGFR)

This outcome measure evaluated renal function by assessing the calculated GFR based on the Cockcroft-Gault formula.

ITT

Posted

Mean

Standard Deviation

mL/min

Month 5

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Incidence of Treated BPAR

The incidence of treated BPAR was estimated using crude rate estimation (relative frequency).

ITT

Posted

Number

Percentage of Participants

Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Patient and Graft Survival

Patient survival was defined as the time from date of randomization to date of death from any cause. If a patient was not known to have died, patient survival was censored as the date of last contact. Graft survival was defined as the time from the date of randomization to the date of graft loss. If a patient was not known to suffer from a graft loss or died without graft loss, time to graft loss was censored with date of last contact or date of death, respectively. Patient and graft survival were analyzed using the Kaplan Meier method.

ITT

Posted

Number

Percentage of Participants

Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants

Secondary

Hepatitis C Virus (HCV) Replication in HCV-positive Patients

HCV ribonucleic acid (RNA) was measured by real time reverse transcriptase polymerase chain reaction (PCR; copies per mL).

ITT

Posted

Number

Percentage of participants

Baseline, Month 5

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.

Posted

Number

Number of participants

From randomization to Month 11

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death

Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported.

Safety population: This set included all randomized patients with at least one post-baseline measurement of GFR.

Posted

Number

Number of participants

Month 12 to Month 59 post-baseline

ID	Title	Description
OG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
OG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG0031 affected40 at risk
DISSEMINATED INTRAVASCULAR COAGULATION	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HAEMOLYTIC URAEMIC SYNDROME	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
THROMBOTIC MICROANGIOPATHY	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ARRHYTHMIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
TORSADE DE POINTES	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GOITRE	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HYPERTHYROIDISM	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
TOXIC NODULAR GOITRE	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
MACULAR OEDEMA	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
OCULAR ICTERUS	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PAPILLOEDEMA	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
RETINAL HAEMORRHAGE	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
RETINITIS	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
ANAL PROLAPSE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0012 affected102 at risk EG0021 affected41 at risk EG003
COELIAC ARTERY STENOSIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
GASTRITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
GASTROINTESTINAL NECROSIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ILEUS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0012 affected102 at risk EG0021 affected41 at risk EG003
ILEUS PARALYTIC	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
INTESTINAL DILATATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
MALABSORPTION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
MECHANICAL ILEUS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
OESOPHAGEAL VARICES HAEMORRHAGE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PANCREATIC CYST	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
SMALL INTESTINAL STENOSIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
SUBILEUS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ASTHENIA	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CHEST PAIN	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CONCOMITANT DISEASE PROGRESSION	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CYST	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DEATH	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DISEASE PROGRESSION	General disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DRUG INEFFECTIVE	General disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DRUG INTERACTION	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HERNIA	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HERNIA PAIN	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
INFLAMMATION	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
MULTI-ORGAN FAILURE	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0014 affected102 at risk EG0022 affected41 at risk EG003
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
BILE DUCT STENOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0015 affected102 at risk EG0021 affected41 at risk EG003
BILIARY ISCHAEMIA	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0014 affected102 at risk EG0022 affected41 at risk EG003
BILIARY TRACT DISORDER	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BILOMA	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CHOLANGITIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG00110 affected102 at risk EG0021 affected41 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CHOLESTASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC ARTERY OCCLUSION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC HAEMORRHAGE	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC LESION	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
HEPATITIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
NON-ALCOHOLIC STEATOHEPATITIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
HYPERSENSITIVITY	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
LIVER TRANSPLANT REJECTION	Immune system disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
TRANSPLANT REJECTION	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ABDOMINAL ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ASPERGILLOSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BILIARY SEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
BRAIN ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BRONCHOPNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
BRONCHOPULMONARY ASPERGILLOSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CELLULITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CELLULITIS ORBITAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
CEREBRAL TOXOPLASMOSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CLOSTRIDIAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CYTOMEGALOVIRUS COLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0015 affected102 at risk EG0021 affected41 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ENDOCARDITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ENTEROCOCCAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GASTROINTESTINAL INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HAEMATOMA INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEPATITIS C	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
HERPES ZOSTER	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
INCISIONAL HERNIA GANGRENOUS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0022 affected41 at risk EG003
LIVER ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PANCREATITIS BACTERIAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PERIHEPATIC ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PERITONEAL ABSCESS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PERITONITIS BACTERIAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PNEUMOCYSTIS JIROVECI PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0013 affected102 at risk EG0021 affected41 at risk EG003
PNEUMONIA CYTOMEGALOVIRAL	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
SEPSIS	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0012 affected102 at risk EG0021 affected41 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
SMALL INTESTINE GANGRENE	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
STENOTROPHOMONAS INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
TONSILLITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ANASTOMOTIC STENOSIS	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
BILIARY ANASTOMOSIS COMPLICATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0023 affected41 at risk EG003
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0015 affected102 at risk EG0027 affected41 at risk EG003
INCISIONAL HERNIA, OBSTRUCTIVE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
LIVER GRAFT LOSS	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0010 affected102 at risk EG0022 affected41 at risk EG003
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0022 affected41 at risk EG003
TRANSPLANT FAILURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BLOOD CREATININE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
CYTOMEGALOVIRUS TEST POSITIVE	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GAMMA-GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA	Systematic Assessment	EG00014 affected101 at risk EG0019 affected102 at risk EG0021 affected41 at risk EG003
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0013 affected102 at risk EG0021 affected41 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HYPOVITAMINOSIS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
OSTEOPENIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
OSTEOPOROTIC FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
EPSTEIN-BARR VIRUS ASSOCIATED LYMPHOPROLIFERATIVE DISORDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEPATIC NEOPLASM MALIGNANT RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEPATOCELLULAR CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0022 affected41 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
METASTASES TO LYMPH NODES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
METASTASES TO PERITONEUM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PARANEOPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
RECTAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
APHASIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ENCEPHALOPATHY	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
EPILEPSY	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
GRAND MAL CONVULSION	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HEMIPARESIS	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
LACUNAR INFARCTION	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
LETHARGY	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
NEUROTOXICITY	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
POLYNEUROPATHY	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
RADICULAR SYNDROME	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
SOMNOLENCE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ALCOHOLISM	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DISORIENTATION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
PSYCHOTIC DISORDER DUE TO A GENERAL MEDICAL CONDITION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
RENAL INJURY	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
MENORRHAGIA	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
OVARIAN CYST	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
SPERMATOCELE	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
TESTICULAR SWELLING	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
VOCAL CORD POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
SCAR	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
TOXIC SKIN ERUPTION	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
STEAL SYNDROME	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
VENA CAVA THROMBOSIS	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
VENOUS STENOSIS	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00017 affected101 at risk EG00110 affected102 at risk EG0024 affected41 at risk EG0031 affected40 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00019 affected101 at risk EG00110 affected102 at risk EG0021 affected41 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0017 affected102 at risk EG0022 affected41 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
HYPOTHYROIDISM	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0021 affected41 at risk EG003
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0020 affected41 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00011 affected101 at risk EG00110 affected102 at risk EG0024 affected41 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0016 affected102 at risk EG0025 affected41 at risk EG003
APHTHOUS STOMATITIS	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0011 affected102 at risk EG0022 affected41 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0018 affected102 at risk EG0021 affected41 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG00111 affected102 at risk EG0021 affected41 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00027 affected101 at risk EG00113 affected102 at risk EG00210 affected41 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 affected101 at risk EG00110 affected102 at risk EG0025 affected41 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0024 affected41 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected101 at risk EG00116 affected102 at risk EG0025 affected41 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG00112 affected102 at risk EG0023 affected41 at risk EG003
FATIGUE	General disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0016 affected102 at risk EG0022 affected41 at risk EG003
IMPAIRED HEALING	General disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0011 affected102 at risk EG0022 affected41 at risk EG003
OEDEMA	General disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0016 affected102 at risk EG0020 affected41 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA	Systematic Assessment	EG00015 affected101 at risk EG0019 affected102 at risk EG00213 affected41 at risk EG003
PYREXIA	General disorders	MedDRA	Systematic Assessment	EG00014 affected101 at risk EG00112 affected102 at risk EG0024 affected41 at risk EG003
CHOLANGITIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0015 affected102 at risk EG0021 affected41 at risk EG003
CHOLESTASIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG0014 affected102 at risk EG0022 affected41 at risk EG003
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0014 affected102 at risk EG0026 affected41 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0011 affected102 at risk EG0026 affected41 at risk EG003
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected101 at risk EG0017 affected102 at risk EG0021 affected41 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA	Systematic Assessment	EG00015 affected101 at risk EG00115 affected102 at risk EG0029 affected41 at risk EG003
PERIODONTITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0025 affected41 at risk EG003
SINUSITIS	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0011 affected102 at risk EG0024 affected41 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0012 affected102 at risk EG0024 affected41 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG00016 affected101 at risk EG00113 affected102 at risk EG0026 affected41 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected101 at risk EG0012 affected102 at risk EG0022 affected41 at risk EG003
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0015 affected102 at risk EG0027 affected41 at risk EG003
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0018 affected102 at risk EG0023 affected41 at risk EG003
C-REACTIVE PROTEIN INCREASED	Investigations	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0012 affected102 at risk EG0022 affected41 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	MedDRA	Systematic Assessment	EG00014 affected101 at risk EG0013 affected102 at risk EG0020 affected41 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0016 affected102 at risk EG0024 affected41 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0016 affected102 at risk EG0025 affected41 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00022 affected101 at risk EG00111 affected102 at risk EG0024 affected41 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0017 affected102 at risk EG0020 affected41 at risk EG003
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected101 at risk EG0012 affected102 at risk EG0021 affected41 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0013 affected102 at risk EG0022 affected41 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0017 affected102 at risk EG0022 affected41 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00013 affected101 at risk EG0019 affected102 at risk EG0023 affected41 at risk EG003
OBESITY	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected101 at risk EG00110 affected102 at risk EG0023 affected41 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00012 affected101 at risk EG00113 affected102 at risk EG0029 affected41 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0017 affected102 at risk EG0021 affected41 at risk EG003
OSTEOPENIA	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0013 affected102 at risk EG0022 affected41 at risk EG003
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected101 at risk EG0014 affected102 at risk EG0026 affected41 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0016 affected102 at risk EG0027 affected41 at risk EG003
MELANOCYTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
HEADACHE	Nervous system disorders	MedDRA	Systematic Assessment	EG00020 affected101 at risk EG00110 affected102 at risk EG0023 affected41 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0014 affected102 at risk EG0023 affected41 at risk EG003
TREMOR	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0019 affected102 at risk EG0020 affected41 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0016 affected102 at risk EG0022 affected41 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA	Systematic Assessment	EG0008 affected101 at risk EG0019 affected102 at risk EG0021 affected41 at risk EG003
SLEEP DISORDER	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected101 at risk EG0016 affected102 at risk EG0024 affected41 at risk EG003
PROTEINURIA	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00010 affected101 at risk EG0012 affected102 at risk EG0024 affected41 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 affected101 at risk EG0017 affected102 at risk EG0022 affected41 at risk EG003
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0012 affected102 at risk EG0020 affected41 at risk EG003
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
METRORRHAGIA	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected101 at risk EG0010 affected102 at risk EG0020 affected41 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0011 affected102 at risk EG0024 affected41 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected101 at risk EG0015 affected102 at risk EG0020 affected41 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected101 at risk EG0018 affected102 at risk EG0021 affected41 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00019 affected101 at risk EG00111 affected102 at risk EG0025 affected41 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 affected101 at risk EG0011 affected102 at risk EG0021 affected41 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA	Systematic Assessment	EG00020 affected101 at risk EG00114 affected102 at risk EG0026 affected41 at risk EG003

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
BG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice	67	101	92	101
EG001	Calcineurin Inhibitor (CNI)	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice	58	102	87	102
EG002	Extension Period - Everolimus	Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice	26	41	39	41
EG003	Extension Period - CNI	Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice	28	40	38	40