A Study of CellCept (Mycophenolate Mofetil) in Combinatio... | NCT00545402

Label	Type	Description	Intervention Names
MMF, Adjusted Dose; Tacrolimus; Corticosteroids	Experimental	Participants received mycophenolate mofetil (MMF) 3 grams per day (g/d), orally (PO), twice per day (BID) with meals from Day 0 to Day 4; the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. Participants also received tacrolimus adjusted to a target trough level of 8 to (-) 12 nanograms per milliliter (ng/mL) from Day 0 to Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 milligrams per kilogram (mg/kg), intravenously (IV), pre-operation on Day 0.	Drug: Mycophenolate mofetil, adjusted dose Drug: Tacrolimus Drug: Corticosteroids, IV
MMF, Standard Dose; Tacrolimus; Corticosteroids	Active Comparator	Participants received MMF 2 g/d, PO, BID with meals from Day 0 to Month 12. Participants also received tacrolimus adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 mg/kg, IV, pre-operation on Day 0; followed by 20 mg/d, PO, 4 times per day (QDS) from Day 0 through Month 1; 15 mg/d, PO, 3 times per day (TID) from the end of Month 1 through Month 2; 10 mg/d, PO, BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.	Drug: Tacrolimus Drug: Corticosteroids, IV Drug: Mycophenolate mofetil, Standard dose Drug: Corticosteroids, PO

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate mofetil, adjusted dose	Drug	3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.

Measure	Description	Time Frame
Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant	Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.	Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment

Measure	Description	Time Frame
Percentage of Participants With Graft Loss	Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.	Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

ID	Title	Description
FG000	Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid	Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.

ID	Title	Description
BG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
BG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00090 BG00190 BG002180

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

Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR) According to Banff Criteria up to 12 Months Post-Transplant

Banff criteria required at least 2 of the 3 following features for a histopathological diagnosis of acute rejection: portal inflammation, bile duct inflammation, and venous endothelial inflammation. Each item was graded from 0 to 3 where 0 equals (=) mild, 2 = moderate, and 3 = severe. The sum of the 3 individual scores, from 0 to 9, corresponded to the Rejection Activity Index (RAI). If RAI = 0, 1, or 2, there was no evidence of rejection. If RAI = 3, there was borderline acute rejection. If RAI = 4 or 5, there was mild acute rejection. If RAI = 6 or 7, there was moderate acute rejection. If RAI = 8 or 9, there was severe acute rejection.

ITT population

Posted

Number

percentage of participants

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Units	Counts
Participants	OG00087 OG00187

Title

Denominators

Categories

Title	Measurements
	OG0008.0 OG0018.2

Secondary

Percentage of Participants With Graft Loss

Graft survival was defined as the time between the randomization date and the graft loss date. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.

ITT population

Posted

Number

percentage of participants

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Secondary

Graft Survival

The median time, in months, between randomization and graft loss event. Participants were censored at the date of last follow up, the date of last contact or premature withdrawal, and date of death.

ITT population

Posted

Median

Full Range

months

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12, 28 days after Month 12 or last dose of study treatment, and 6 and 12 months after the last dose of study treatment.

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Secondary

Overall Survival (OS) at Month 12 - Percentage of Participants With an Event

OS was defined as the time between the date of randomization and death up to Month 12. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.

ITT population

Posted

Number

percentage of participants

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Secondary

Overall Survival at Month 12

The median time, in months, between randomization and OS event. Participants were censored at the date of last follow up and the date of last contact or premature withdrawal.

ITT population

Posted

Median

Full Range

months

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Secondary

Percentage of Participants by Graft Histology at 12 Months Post-Transplant - Central Review

The percentage of participants with biopsies of grafts evaluated by central review and scored according to Banff criteria at Month 12 post-transplant.

ITT population; only participants with evaluable biopsies were included in the analysis.

Posted

Number

percentage of participants

Days 0, 5, and 14, Month 1, 2, 3, 6, 9, and 12

ID	Title	Description
OG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
OG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hepatitis C	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0017 affected92 at risk
Sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0014 affected92 at risk
Septic shock	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0011 affected92 at risk
Peritoneal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Biliary sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Candida sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Appendicitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Arthritis bacterial	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Aspergillosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Bacterial sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Device related infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Enterocolitis infectious	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatitis E	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Herpes zoster	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Liver abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Nocardiosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Systemic candida	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Viral diarrhoea	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG0012 affected92 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0014 affected92 at risk
Ascites	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected92 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0014 affected92 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0014 affected92 at risk
Hepatic artery thrombosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0015 affected92 at risk
Hepatic artery stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0012 affected92 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0014 affected92 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Bile duct necrosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Biliary cyst	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatic artery aneurysm	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatic vein stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG00014 affected91 at risk EG0015 affected92 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG0016 affected92 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary anastomosis complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0016 affected92 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0014 affected92 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Complications of transplanted liver	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Multi-organ failure	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0013 affected92 at risk
General physical health deterioration	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Chest pain	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Pyrexia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Sudden death	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Hyperthermia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Inflammation	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Malaise	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ulcer haemorrhage	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0014 affected92 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0013 affected92 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Aneurysm	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Angiopathy	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Arterial stenosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Haematoma	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Haemodynamic instability	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Vascular stenosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Venous thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Cell death	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Epilepsy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Coma	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Convulsion	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Febrile convulsion	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Vocal cord paresis	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Confusional state	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Mental disorder	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Delirium	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Liver function test abnormal	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Cytomegalovirus antibody positive	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Biliary anastomosis	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary drainage	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Catheter removal	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Surgical vascular shunt	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hereditary neuropathic amyloidosis	Congenital, familial and genetic disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Liver transplant rejection	Immune system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00031 affected91 at risk EG00126 affected92 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00012 affected91 at risk EG00112 affected92 at risk
Ascites	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0009 affected91 at risk EG00111 affected92 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG00111 affected92 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG0018 affected92 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00010 affected91 at risk EG0015 affected92 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0017 affected92 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0017 affected92 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0015 affected92 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0013 affected92 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected92 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Subileus	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Coeliac artery stenosis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Duodenitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Melaena	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Oesophagitis ulcerative	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Peritoneal effusion	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Portal venous gas	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Small bowel angioedema	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Toothache	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Volvulus of small bowel	Gastrointestinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG00045 affected91 at risk EG00144 affected92 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG00016 affected91 at risk EG00113 affected92 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG00013 affected91 at risk EG0016 affected92 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG00014 affected91 at risk EG0012 affected92 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG00011 affected91 at risk EG0014 affected92 at risk
Deficiency anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG0013 affected92 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0013 affected92 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Idiopathic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Jaundice acholuric	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG00013 affected91 at risk EG00114 affected92 at risk
Hepatitis C	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG00111 affected92 at risk
Sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0009 affected91 at risk EG0018 affected92 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG0016 affected92 at risk
Staphylococcal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0016 affected92 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0015 affected92 at risk
Septic shock	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0012 affected92 at risk
Infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0011 affected92 at risk
Puncture site infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0012 affected92 at risk
Abdominal wall abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Ascites infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Enterococcal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0010 affected92 at risk
Lung infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Peritoneal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Oral candidiasis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Tonsillitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Arthritis bacterial	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Biliary sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Candida sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Catheter related infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Clostridial infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Device related infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Fungal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Herpes zoster	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Postoperative wound infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Streptococcal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Appendicitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Aspergillosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Bacterial infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Bacterial sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Candidiasis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cellulitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cholecystitis infective	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Citrobacter infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cystitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Endocarditis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Enterobacter bacteraemia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Enterocolitis infectious	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Furuncle	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatitis E	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatobiliary infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Herpes simplex	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Influenza	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Infusion site infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Liver abscess	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Nocardiosis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Oral fungal infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Orchitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Paronychia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pneumocystis jiroveci pneumonia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Rhinitis	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Serratia infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Skin infection	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Systemic candida	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Viral diarrhoea	Infections and infestations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG00015 affected91 at risk EG00114 affected92 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG00119 affected92 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG00011 affected91 at risk EG00113 affected92 at risk
Cell death	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG00012 affected91 at risk EG0018 affected92 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0018 affected92 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0013 affected92 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0015 affected92 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0014 affected92 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Weight fluctuation	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Gout	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Mineral deficiency	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG00031 affected91 at risk EG00131 affected92 at risk
Venous thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG0014 affected92 at risk
Haemodynamic instability	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0017 affected92 at risk
Haemorrhage	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0014 affected92 at risk
Hypotension	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected92 at risk
Haematoma	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Shock haemorrhagic	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Vein discolouration	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Aneurysm	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Angiopathy	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Arterial stenosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Lymphoedema	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Phlebitis	Metabolism and nutrition disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Thrombophlebitis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Thrombosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Vascular stenosis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Venous stasis	Vascular disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG00024 affected91 at risk EG00123 affected92 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG00022 affected91 at risk EG00116 affected92 at risk
Renal impairment	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG0018 affected92 at risk
Oliguria	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0015 affected92 at risk
Anuria	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Dysuria	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Micturition disorder	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Polyuria	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Renal colic	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Renal pain	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Renal tubular disorder	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Urinary retention	Renal and urinary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oedema peripheral	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG00010 affected91 at risk EG00117 affected92 at risk
Pain	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG00012 affected91 at risk EG00110 affected92 at risk
Pyrexia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG00011 affected91 at risk EG0014 affected92 at risk
Hyperthermia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG0015 affected92 at risk
Oedema	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG0015 affected92 at risk
Multi-organ failure	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0015 affected92 at risk
Asthenia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0016 affected92 at risk
Inflammation	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0015 affected92 at risk
Chest pain	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
General physical health deterioration	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Hypothermia	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Effusion	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Influenza like illness	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Sudden death	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Catheter site necrosis	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Chills	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Generalised oedema	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Malaise	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Necrosis	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Polyp	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ulcer	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ulcer haemorrhage	General disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG00024 affected91 at risk EG00119 affected92 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0016 affected92 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0014 affected92 at risk
Hepatic artery thrombosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0017 affected92 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0013 affected92 at risk
Hepatic artery stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0013 affected92 at risk
Jaundice	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0012 affected92 at risk
Biliary fistula	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected92 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0011 affected92 at risk
Biloma	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Biliary cyst	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Bile duct necrosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatic artery aneurysm	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatic ischaemia	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatic vein stenosis	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00022 affected91 at risk EG00125 affected92 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG00013 affected91 at risk EG0019 affected92 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0011 affected92 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected92 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected92 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hydropneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Respiratory gas exchange disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Confusional state	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG00011 affected91 at risk EG00114 affected92 at risk
Insomnia	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG00015 affected91 at risk EG00110 affected92 at risk
Agitation	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG0018 affected92 at risk
Anxiety	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG00112 affected92 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0016 affected92 at risk
Delirium	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Mental disorder	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Affective disorder	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hallucination	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Sleep disorder	Psychiatric disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0009 affected91 at risk EG00110 affected92 at risk
Tremor	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG0019 affected92 at risk
Convulsion	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0014 affected92 at risk
Febrile convulsion	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0011 affected92 at risk
Encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Dysarthria	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Epilepsy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Paraesthesia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Syncope vasovagal	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected92 at risk
Amnesia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Polyneuropathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Somnolence	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Aphonia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cognitive disorder	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Coma	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hyperreflexia	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Memory impairment	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Paresis	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Psychomotor skills impaired	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Vocal cord paresis	Nervous system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary anastomosis complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG0016 affected92 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0015 affected92 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0016 affected92 at risk
Anastomotic stenosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0014 affected92 at risk
Eschar	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Hepatic haematoma	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0013 affected92 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0010 affected92 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0010 affected92 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Endotracheal intubation complication	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0010 affected92 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Complications of transplanted liver	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Poisoning	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Radiation leukopenia	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Surgical procedure repeated	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Wound evisceration	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0007 affected91 at risk EG0017 affected92 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0005 affected91 at risk EG0014 affected92 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0013 affected92 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Hypercreatinaemia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Band neutrophil percentage decreased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0015 affected92 at risk
Weight decreased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0004 affected91 at risk EG0015 affected92 at risk
Red blood cell count decreased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0014 affected92 at risk
Liver function test abnormal	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0015 affected92 at risk
Weight increased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0012 affected92 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0011 affected92 at risk
Blood bilirubin increased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Blood urea increased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Haematology test abnormal	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Aspiration tracheal	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Blood glucose	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cytomegalovirus antibody positive	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oesophagogastroduodenoscopy	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Prothrombin level decreased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Serum ferritin increased	Investigations	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Tachycardia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0006 affected91 at risk EG0011 affected92 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0003 affected91 at risk EG0013 affected92 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0012 affected92 at risk
Arrhythmia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0013 affected92 at risk
Bradycardia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Pericardial effusion	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Atrial flutter	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cardiac failure	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Palpitations	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pericardial disease	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0008 affected91 at risk EG0013 affected92 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0014 affected92 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0002 affected91 at risk EG0011 affected92 at risk
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Vascular purpura	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0013 affected92 at risk
Hypersensitivity	Immune system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Liver transplant rejection	Immune system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Transplant rejection	Immune system disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0012 affected92 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Oedema genital	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Visual acuity reduced	Eye disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0012 affected92 at risk
Visual disturbance	Eye disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0011 affected92 at risk
Uveitis	Eye disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary anastomosis	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Biliary drainage	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Catheter removal	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Surgical vascular shunt	Surgical and medical procedures	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hereditary neuropathic amyloidosis	Congenital, familial and genetic disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (11.0)	Non-systematic Assessment	EG0001 affected91 at risk EG0010 affected92 at risk
Alcohol use	Social circumstances	MedDRA (11.0)	Non-systematic Assessment	EG0000 affected91 at risk EG0011 affected92 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Besançon		25030	France

ID	Term
D009173	Mycophenolic Acid
D016559	Tacrolimus
D000305	Adrenal Cortex Hormones
D008776	Methylprednisolone Hemisuccinate
D011241	Prednisone

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D018942	Macrolides
D007783	Lactones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D008775	Methylprednisolone
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Adjusted MMF + Tacrolimus + CS	Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.			70	91	91	91
EG001	Fixed-Dose MMF + Tacrolimus + CS	Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.			69	92	91	92