Safety/Efficacy of Induction Agents With Tacrolimus, MMF,... | NCT00113269

Label	Type	Description	Intervention Names
Alemtuzumab High-Risk Patients	Experimental	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American	Drug: tacrolimus Drug: alemtuzumab Drug: mycophenolate mofetil Drug: steroids
Conventional High-Risk Patients	Active Comparator	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American	Drug: rabbit anti-thymocyte globulin Drug: tacrolimus Drug: mycophenolate mofetil Drug: steroids
Alemtuzumab Low- Risk Patients	Experimental	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American	Drug: tacrolimus Drug: alemtuzumab Drug: mycophenolate mofetil Drug: steroids
Conventional Low-Risk Patients	Active Comparator	Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American	Drug: basiliximab Drug: tacrolimus Drug: mycophenolate mofetil Drug: steroids

Name	Type	Description	Arm Group Labels	Other Names
basiliximab	Drug	IV	Conventional Low-Risk Patients	simulect

Measure	Description	Time Frame
Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months	A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3). Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.	6 months

Measure	Description	Time Frame
Overall Patient Incidence of BCAR	Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3). End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Name	Affiliation	Role
Central Contact	Astellas Pharma Global Development	Study Director

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

PubMed Identifier	Type	Citation	Retractions
21591943	Background	Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.

Label	URL
Link to Prescribing Information	View source

ID	Title	Description
FG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
FG001	Conventional High-Risk Patients

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

Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months

A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) & Severe (3).

Kaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.

The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.

Posted

Number

95% Confidence Interval

Percentage of Patients

6 months

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
OG003	Conventional Low-Risk Patients	Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Units	Counts
Participants	OG00070 OG00169 OG002164 OG003

Title

Denominators

Categories

Title	Measurements
	OG0006.2(0.3 to 12.0) OG0019.4(2.2 to 16.7) OG0021.9(0.0 to 4.0) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Normal approximation	Analysis based on normal approximation using Greenwood's formula for standard error.	0.4889		differences in event rates	-3.3			2-Sided	95.305	-12.7	6.1			95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.	No	Superiority or Other

Secondary

Overall Patient Incidence of BCAR

Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A & 1B) to Moderate (2A & 2B) to Severe (3).

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Posted

Number

Percentage of Patients

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients

Secondary

Efficacy Failure

Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Posted

Number

Percentage of Patients

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Clinically Treated Acute Rejection

Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Posted

Number

Percentage of Patients

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Time to First BCAR

Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Only patients who experienced BCAR were included in the analysis.

Posted

Median

Full Range

Days

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Graft Survival at 12 Months

Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.

Kaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.

Posted

Number

Percentage of Patients

12 months

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients

Secondary

Overall Graft Survival

Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Posted

Number

Percentage of Patients

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Patient Survival at 12 Months

Patient survival is defined as not dead within 12 months after skin closure.

Posted

Number

Percentage of Patients

12 months

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients

Secondary

Overall Patient Survival

Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.

End of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.

Posted

Number

Percentage of Patients

End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Renal Function Abnormalities Based on Creatinine Clearance

Increases in creatinine clearance usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.

The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as "N".

Posted

Mean

Standard Deviation

mL/s

1 month and End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Secondary

Renal Function Abnormalities Based on Serum Creatinine

Decrease in serum creatinine usually indicates an improvement.

Change in creatinine clearance from month 1 was calculated.

Change from 1 month is calculated by month 36 - month 1.

Posted

Mean

Standard Deviation

mcmol/L

1 month and End of Study (36 months)

ID	Title	Description
OG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
OG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0016 affected69 at risk EG0026 affected164 at risk EG0032 affected171 at risk
Urinary tract infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0004 affected70 at risk EG0012 affected69 at risk EG0024 affected164 at risk EG003
Bk virus infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0012 affected69 at risk EG0022 affected164 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0013 affected69 at risk EG0025 affected164 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Cytomegalovirus infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0026 affected164 at risk EG003
Cytomegalovirus viraemia	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0023 affected164 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0025 affected164 at risk EG003
Sepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0021 affected164 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Candidiasis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Cellulitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Cytomegalovirus colitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Endocarditis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Influenza	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Lung infection pseudomonal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pneumonia aspergillus	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pneumonia cytomegaloviral	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Sinusitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Urosepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0027 affected164 at risk EG003
Viral infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Wound infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Appendicitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Gangrene	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Orchitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Bronchiectasis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Campylobacter intestinal infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Candida osteomyelitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Clostridium colitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Coccidioidomycosis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Cryptococcosis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Cytomegalovirus oesophagitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Ear infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Gastroenteritis norwalk virus	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Human polyomavirus infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Klebsiella bacteraemia	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Meningitis viral	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pericarditis infective	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pneumococcal infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pneumonia fungal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pneumonitis cryptococcal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Postoperative infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Respiratory tract infection fungal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Tinea versicolour	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Varicella	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
West nile viral infection	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Wound sepsis	Infections and infestations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Blood creatinine increased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0005 affected70 at risk EG0015 affected69 at risk EG0027 affected164 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Immunosuppressant drug level increased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pulmonary function test increased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Protein urine present	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Bacteria urine identified	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Blood culture positive	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Cytomegalovirus antigen positive	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Troponin increased	Investigations	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0004 affected70 at risk EG0012 affected69 at risk EG0026 affected164 at risk EG003
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Post procedural urine leak	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Renal lymphocele	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Stenosis of vesicourethral anastomosis	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Transplant failure	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Treatment noncompliance	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0023 affected164 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Fluid retention	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0024 affected164 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Metabolic disorder	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0020 affected164 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0020 affected164 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Hypotension	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Aneurysm arteriovenous	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Lymphocele	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Subclavian vein thrombosis	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Hypertension	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Necrosis ischaemic	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Peripheral occlusive disease	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0024 affected164 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Haemolytic uraemic syndrome	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0028 affected164 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Thrombotic microangiopathy	Blood and lymphatic system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0021 affected164 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0022 affected164 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0022 affected164 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0023 affected164 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Coronary artery atherosclerosis	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Chest pain	General disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0012 affected69 at risk EG0020 affected164 at risk EG003
Death	General disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Heparin-induced thrombocytopenia	General disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Pyrexia	General disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Chills	General disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Transplant rejection	Immune system disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0013 affected69 at risk EG0020 affected164 at risk EG003
Kidney transplant rejection	Immune system disorders	MedDRA (8.0)	Systematic Assessment	EG0002 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Nephropathy	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Renal failure chronic	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Nephritis interstitial	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Pelvi-ureteric obstruction	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Renal vein thrombosis	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0021 affected164 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0023 affected164 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Portal hypertension	Hepatobiliary disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Leukoencephalopathy	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Mental impairment	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Convulsion	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Headache	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Petit mal epilepsy	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Knee arthroplasty	Surgical and medical procedures	MedDRA (8.0)	Systematic Assessment	EG0001 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Parathyroidectomy	Surgical and medical procedures	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Hyperparathyroidism	Endocrine disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Hyperparathyroidism tertiary	Endocrine disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0022 affected164 at risk EG003
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0011 affected69 at risk EG0020 affected164 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0023 affected164 at risk EG003
Depression	Psychiatric disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Mania	Psychiatric disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Adnexa uteri mass	Reproductive system and breast disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Epididymitis	Reproductive system and breast disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0020 affected164 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (8.0)	Systematic Assessment	EG0000 affected70 at risk EG0010 affected69 at risk EG0021 affected164 at risk EG003

ID	Term
D000077552	Basiliximab
D000961	Antilymphocyte Serum
C512542	thymoglobulin
D016559	Tacrolimus
D000074323	Alemtuzumab
D009173	Mycophenolic Acid
D013256	Steroids

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D007106	Immune Sera
D001688	Biological Products
D045424	Complex Mixtures
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
BG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
BG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
BG003	Conventional Low-Risk Patients	Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Alemtuzumab High-Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American	33	70	61	70
EG001	Conventional High-Risk Patients	Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American	40	69	66	69
EG002	Alemtuzumab Low- Risk Patients	Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American	91	164	151	164
EG003	Conventional Low-Risk Patients	Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American	81	171	157	171