Combination Immunosuppressive Therapy to Prevent Kidney T... | NCT00078559

ID	Type	Description	Link
H-2003-0435	Other Identifier	HS IRB

Name	Class
Immune Tolerance Network (ITN)	NETWORK

Label	Type	Description	Intervention Names
Alemtuzumab	Experimental		Drug: Alemtuzumab Drug: Sirolimus Drug: Tacrolimus Procedure: Kidney transplant Drug: Methylprednisolone (or equivalent) Drug: Acetaminophen Drug: Diphenhydramine Drug: Trimethoprim (TMP)/Sulfa (Bactrim, Septra) Drug: Valgancyclovir Drug: Acyclovir Drug: Pentamidine Drug: Clotrimazole Drug: Nystatin

Name	Type	Description	Arm Group Labels	Other Names
Alemtuzumab	Drug	30mg intravenous infusion on days 0 (transplant), 1, and 2	Alemtuzumab

Measure	Description	Time Frame
Number of Acute Rejections in All Enrolled Participants	Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant) Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999	Four years post-transplant

Measure	Description	Time Frame
Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal	Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants 1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine. [2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Name	Affiliation	Role
A. D'jamali, MD, MS	Immune Tolerance Network (ITN)	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin - Department of Medicine		Madison	Wisconsin	53792-1735	United States

PubMed Identifier	Type	Citation	Retractions
15599882	Background	First MR. Tacrolimus based immunosuppression. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S25-31.
12079485	Background	Gourishankar S, Turner P, Halloran P. New developments in immunosuppressive therapy in renal transplantation. Expert Opin Biol Ther. 2002 Jun;2(5):483-501. doi: 10.1517/14712598.2.5.483.

Label	URL
Click here for the Immune Tolerance Network Web site	View source

ID	Title	Description
FG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

ID	Title	Description
BG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Units	Counts
Participants	BG00010

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Acute Rejections in All Enrolled Participants

Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)

Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Intent-to-treat

Posted

Number

Rejection Events

Four years post-transplant

ID	Title	Description
OG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Units	Counts
Participants	OG00010

Title

Denominators

Categories

Title	Measurements
	OG0001

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		95% Confidence Interval	Exact Binomial			Proportion with acute rejection	0.1			2-Sided	95	0.01	0.34					Superiority or Other

Secondary

Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal

Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants

1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Intent-to-treat

Posted

Number

Rejection Events

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Units	Counts

Secondary

Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study

Acute rejections[1] between initiation of sirolimus withdrawal and end of study

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Sirolimus withdrawal initiation participant sample

Posted

Number

Rejection Events

Initiation of sirolimus to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Units	Counts

Secondary

Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated

Time (days) to acute rejection[1] for participants where sirolimus was not initiated

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Participants for whom sirolimus withdrawal was not initiated

Posted

Number

Days

Transplantation to acute rejection (up to four years post-transplantation)

ID	Title	Description
OG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Units	Counts

Secondary

Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period

Time (days) to acute rejection[1] for participants occurring during the year following transplantation

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Participants with acute rejections for whom sirolimus withdrawal was not initiated

Posted

Number

Days

Transplantation to acute rejection (up to one year post-transplant)

ID	Title	Description
OG000	Alemtuzumab	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated

Secondary

Number of Deaths Stratified by Sirolimus Withdrawal Status

Participants who died during the study, all cause(s)

Intent-to-treat

Posted

Number

deaths

Transplantation to Death (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status

Participants who experienced graft loss[1] during study

[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation

Intent-to-treat

Posted

Number

participants

Transplantation to Graft Loss (up to four years post-transplantation)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status

Participants who experienced severe acute rejections[1] during study

Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]
Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Intent-to-treat

Posted

Number

Rejection Events

Transplantation to severe acute rejection (up to four years post-transplantation)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status

Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy

1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.

[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999

Intent-to-treat

Posted

Number

participants

Transplantation to acute rejection (up to four years post-transplantation)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)

Secondary

Number of Alemtuzumab Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

Intent-to-treat

Posted

Number

adverse events

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Tacrolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

Intent-to-treat

Posted

Number

adverse events

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Sirolimus Associated Adverse Events, Stratified by Sirolimus Withdrawal Status

Intent-to-treat

Posted

Number

adverse events

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status

Side effects of conventional immunosuppression include increased body weight and hypertension

Intent-to-treat

Posted

Number

side effects

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Secondary

Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status

Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 - 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function

Intent-to-treat

Posted

Mean

Standard Deviation

mg/dL

Transplantation to end of study (up to four years post-transplant)

ID	Title	Description
OG000	Alemtuzumab (Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
OG001	Alemtuzumab (Not Withdrawn From Sirolimus)	Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00017 events8 affected10 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00014 events8 affected10 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG00010 events10 affected10 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0004 events3 affected10 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0002 events1 affected10 at risk
Pericardial effusion	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0006 events5 affected10 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Tachycardia	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Cushingoid	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 11.1	Systematic Assessment	EG0003 events1 affected10 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Blepharospasm	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Cataract	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Conjunctivitis	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Eyelid oedema	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Vision blurred	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Visual acuity reduced	Eye disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected10 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 events5 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00014 events6 affected10 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Eructation	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0007 events7 affected10 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Ileus	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG00010 events6 affected10 at risk
Sensitivity of teeth	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Toothache	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 events3 affected10 at risk
Chills	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Fatigue	General disorders	MedDRA 11.1	Systematic Assessment	EG0007 events5 affected10 at risk
Gait disturbance	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Generalised oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0006 events5 affected10 at risk
Infusion site extravasation	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Malaise	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Oedema	General disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Oedema peripheral	General disorders	MedDRA 11.1	Systematic Assessment	EG00019 events9 affected10 at risk
Pain	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pyrexia	General disorders	MedDRA 11.1	Systematic Assessment	EG00011 events6 affected10 at risk
Xerosis	General disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Gallbladder polyp	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hypersensitivity	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Seasonal allergy	Immune system disorders	MedDRA 11.1	Systematic Assessment	EG0005 events3 affected10 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Chromoblastomycosis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Eyelid folliculitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Folliculitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events1 affected10 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0005 events3 affected10 at risk
Herpes zoster	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Human polyomavirus infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Incision site cellulitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Influenza	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Klebsiella infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Oral candidiasis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Oral herpes	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pharyngitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pneumonia cryptococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0009 events4 affected10 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0008 events5 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0004 events2 affected10 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Urinary tract infection staphylococcal	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0002 events1 affected10 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Chronic allograft nephropathy	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Complications of transplanted kidney	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Dialysis device complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Drug toxicity	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00012 events10 affected10 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG00012 events10 affected10 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Open wound	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Perinephric collection	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Renal injury	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Alanine aminotransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected10 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0007 events5 affected10 at risk
Blood creatinine increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0006 events4 affected10 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0007 events6 affected10 at risk
Breath sounds abnormal	Investigations	MedDRA 11.1	Systematic Assessment	EG00012 events10 affected10 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0006 events4 affected10 at risk
Oxygen saturation decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Urine output decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Weight decreased	Investigations	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Weight increased	Investigations	MedDRA 11.1	Systematic Assessment	EG0008 events6 affected10 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected10 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Gout	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG00011 events9 affected10 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0007 events6 affected10 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 events3 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events5 affected10 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected10 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events4 affected10 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Burning sensation	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Headache	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0006 events3 affected10 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Tremor	Nervous system disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Agitation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Disorientation	Psychiatric disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Dysuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected10 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hydroureter	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0003 events3 affected10 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 events1 affected10 at risk
Proteinuria	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0006 events4 affected10 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Renal infarct	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Ureteral disorder	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Urinary retention	Renal and urinary disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0004 events3 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0005 events4 affected10 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0003 events2 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0004 events2 affected10 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG00011 events10 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0005 events5 affected10 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.1	Systematic Assessment	EG0006 events6 affected10 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Flushing	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0002 events2 affected10 at risk
Haematoma	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG00010 events6 affected10 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0004 events4 affected10 at risk
Lymphocele	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 events1 affected10 at risk

ID	Term
D007674	Kidney Diseases
D051437	Renal Insufficiency

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

ID	Term
D000074323	Alemtuzumab
D020123	Sirolimus
D016559	Tacrolimus
D016030	Kidney Transplantation
D008775	Methylprednisolone
D000082	Acetaminophen
D004155	Diphenhydramine
D014295	Trimethoprim
D015662	Trimethoprim, Sulfamethoxazole Drug Combination
D000212	Acyclovir
D010419	Pentamidine
D003022	Clotrimazole
D009761	Nystatin

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
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D017582	Renal Replacement Therapy
D013812	Therapeutics
D016377	Organ Transplantation
D014180	Transplantation
D013514	Surgical Procedures, Operative
D013520	Urologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines
D005021	Ethylamines
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013420	Sulfamethoxazole
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D013424	Sulfanilamides
D013450	Sulfones
D013457	Sulfur Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D001550	Benzamidines
D000578	Amidines
D007093	Imidazoles
D001393	Azoles