Trial Outcomes & Findings for Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients (NCT NCT00105235)

Last Updated: 2012-12-27

Results Overview

Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Within 1 year of post-transplantation

Results posted on

2012-12-27

Participant Flow

Recruitment details: Eight centers in the United States and one center in Canada enrolled 27 participants with end-stage liver disease who met entry criteria between February 2005 and May 2006.

Participant milestones

Participant milestones
Measure	Alemtuzumab Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Overall Study STARTED	27
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Alemtuzumab Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Overall Study Death	4
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab n=27 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	52.5 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 1 year of post-transplantation

Population: Safety Sample

Outcome measures

Outcome measures
Measure	Alemtuzumab n=27 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Remains Off Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Restarted Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Discontinued Immunosuppression Withdrawal Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Proportion of Participants Who Have Graft Loss or Death	0.22 Proportion of Participants	—	—	—

SECONDARY outcome

Timeframe: Within 2 years after initiation of immunosuppression withdrawal

Population: Participants who initiated immunosuppression withdrawal

Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal

Outcome measures

Outcome measures
Measure	Alemtuzumab n=10 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Remains Off Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Restarted Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Discontinued Immunosuppression Withdrawal Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Proportion of Participants Who Had Graft Loss or Death	0 Proportion of Participants	—	—	—

SECONDARY outcome

Timeframe: From transplantation until study completion or participant termination (participants followed up to 60 months)

Population: Safety Sample

Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable)

Outcome measures

Outcome measures
Measure	Alemtuzumab n=17 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Remains Off Immunosuppression n=2 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Restarted Immunosuppression n=2 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Discontinued Immunosuppression Withdrawal n=6 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Number of Events: Immunosuppression-related Complications Acute Rejection	6 Events	0 Events	0 Events	0 Events
Number of Events: Immunosuppression-related Complications Chronic Rejection	1 Events	0 Events	0 Events	0 Events
Number of Events: Immunosuppression-related Complications Post-transplant Infection	76 Events	2 Events	10 Events	11 Events
Number of Events: Immunosuppression-related Complications Post-transplant Malignancies	1 Events	0 Events	0 Events	0 Events
Number of Events: Immunosuppression-related Complications Post-transplant Diabetes	0 Events	0 Events	0 Events	1 Events
Number of Events: Immunosuppression-related Complications Post-transplant Renal Failure	11 Events	0 Events	2 Events	1 Events

SECONDARY outcome

Timeframe: From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Alemtuzumab n=27 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Remains Off Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Restarted Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Discontinued Immunosuppression Withdrawal Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Proportion of Participants Successfully Withdrawn From Immunosuppressants	0.2 Proportion of Participants	—	—	—

SECONDARY outcome

Timeframe: From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)

Population: Intent-to-treat

This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal.

Outcome measures

Outcome measures
Measure	Alemtuzumab n=27 Participants Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Remains Off Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Completed Withdrawal and Restarted Immunosuppression Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression	Discontinued Immunosuppression Withdrawal Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants	0.1 Proportion of Participants	—	—	—

Adverse Events

Alemtuzumab

Serious events: 27 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Alemtuzumab n=27 participants at risk Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Hepatobiliary disorders Cholestasis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hepatic artery thrombosis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hepatic cirrhosis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hepatic failure	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Anaemia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Coagulopathy	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Neutropenia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Pancytopenia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Thrombocytopenia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Bradycardia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Cardio-respiratory arrest	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Tachycardia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Ventricular tachycardia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Abdominal discomfort	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Ascites	3.7% 1/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Gastric ileus	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Gastrointestinal haemorrhage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Oesophageal varices haemorrhage	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Peritoneal haemorrhage	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Umbilical hernia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Varices oesophageal	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Chest pain	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Multi-organ failure	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Pyrexia	7.4% 2/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Bile duct stenosis	22.2% 6/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hepatic steatosis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Liver disorder	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Immune system disorders Hypersensitivity	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Immune system disorders Transplant rejection	33.3% 9/27 • Number of events 12 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Abdominal infection	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Bacteraemia	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Clostridium difficile colitis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Endocarditis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Gastroenteritis viral	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Hydrocele male infected	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Influenza	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Liver abscess	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Lung infection pseudomonal	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Osteomyelitis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Peritonitis bacterial	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Pneumonia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Sepsis	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Urinary tract infection	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Urinary tract infection enterococcal	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Wound infection	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Collapse of lung	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Femoral neck fracture	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Graft loss	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Hip fracture	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Post procedural haemorrhage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Road traffic accident	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Venous injury	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Weaning failure	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Liver function test abnormal	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperkalaemia	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypoglycaemia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Metabolic acidosis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign small intestinal neoplasm	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Central pontine myelinolysis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Mental status changes	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Paranoia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Renal failure	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Renal failure acute	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Renal tubular necrosis	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Reproductive system and breast disorders Menorrhagia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Hypercapnia	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Pleural effusion	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Respiratory arrest	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Respiratory distress	3.7% 1/27 • Number of events 1 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Respiratory failure	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Deep vein thrombosis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)

Other adverse events

Other adverse events
Measure	Alemtuzumab n=27 participants at risk Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (\<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
Nervous system disorders Headache	33.3% 9/27 • Number of events 13 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Neurotoxicity	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Sciatica	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Anaemia	66.7% 18/27 • Number of events 36 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Coagulopathy	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Leukopenia	37.0% 10/27 • Number of events 16 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Lymphopenia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Neutropenia	25.9% 7/27 • Number of events 9 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Splenomegaly	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Blood and lymphatic system disorders Thrombocytopenia	33.3% 9/27 • Number of events 16 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Atrial fibrillation	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Bradycardia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Palpitations	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Pericardial effusion	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Cardiac disorders Tachycardia	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Ear and labyrinth disorders Ear pain	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Endocrine disorders Hypothyroidism	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Eye disorders Ocular icterus	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Abdominal discomfort	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Abdominal distension	33.3% 9/27 • Number of events 13 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Abdominal pain	40.7% 11/27 • Number of events 16 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Abdominal pain upper	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Ascites	18.5% 5/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Dizziness	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Constipation	63.0% 17/27 • Number of events 30 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Diarrhoea	55.6% 15/27 • Number of events 23 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Diverticulum	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Dyspepsia	18.5% 5/27 • Number of events 6 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Dysphagia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Flatulence	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Ileus	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Nausea	59.3% 16/27 • Number of events 24 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Umbilical hernia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Gastrointestinal disorders Vomiting	18.5% 5/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Asthenia	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Fatigue	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Generalised oedema	22.2% 6/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Oedema	22.2% 6/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Oedema peripheral	59.3% 16/27 • Number of events 24 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Pain	40.7% 11/27 • Number of events 17 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
General disorders Pyrexia	48.1% 13/27 • Number of events 25 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Cholangitis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Cholestasis	22.2% 6/27 • Number of events 6 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hepatic steatosis	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Hyperbilirubinaemia	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Hepatobiliary disorders Jaundice	33.3% 9/27 • Number of events 11 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Bacteraemia	14.8% 4/27 • Number of events 6 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Cellulitis	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Dysarthria	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Clostridium difficile colitis	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Cytomegalovirus infection	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Fungal skin infection	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Localised infection	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Peritoneal infection	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Pneumonia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Sinusitis	7.4% 2/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Urinary tract infection	18.5% 5/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Infections and infestations Wound infection	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Endotracheal intubation complication	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Incision site pain	25.9% 7/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Incisional hernia	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Operative haemorrhage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Post procedural bile leak	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Post procedural haemorrhage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Procedural complication	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Procedural hypotension	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Procedural pain	29.6% 8/27 • Number of events 9 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Injury, poisoning and procedural complications Wound secretion	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Blood alkaline phosphatase increased	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Blood creatinine increased	25.9% 7/27 • Number of events 15 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Blood magnesium decreased	14.8% 4/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Blood phosphorus decreased	7.4% 2/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Breath sounds abnormal	14.8% 4/27 • Number of events 6 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Cardiac murmur	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Coagulation time prolonged	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Electrocardiogram abnormal	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Haematocrit decreased	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Hepatic enzyme increased	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations International normalised ratio increased	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Liver function test abnormal	29.6% 8/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Investigations Platelet count decreased	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Acidosis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Anorexia	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Cachexia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Decreased appetite	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Dehydration	25.9% 7/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Failure to thrive	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Fluid overload	22.2% 6/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperglycaemia	51.9% 14/27 • Number of events 19 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperkalaemia	51.9% 14/27 • Number of events 24 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperlipidaemia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyperphosphataemia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypoalbuminaemia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypocalcaemia	29.6% 8/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypoglycaemia	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypokalaemia	51.9% 14/27 • Number of events 21 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypomagnesaemia	37.0% 10/27 • Number of events 19 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hyponatraemia	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypophosphataemia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Hypovolaemia	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Metabolic acidosis	11.1% 3/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Metabolism and nutrition disorders Metabolic alkalosis	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Back pain	29.6% 8/27 • Number of events 10 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Muscle atrophy	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Muscle spasms	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Nervous system disorders Tremor	25.9% 7/27 • Number of events 9 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Agitation	22.2% 6/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Anxiety	25.9% 7/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Confusional state	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Depression	25.9% 7/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Insomnia	55.6% 15/27 • Number of events 20 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Psychiatric disorders Mental status changes	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Renal failure	25.9% 7/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Renal and urinary disorders Renal failure acute	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Reproductive system and breast disorders Scrotal oedema	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Atelectasis	22.2% 6/27 • Number of events 6 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Cough	18.5% 5/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Dysphonia	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.5% 5/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Nasal congestion	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Pleural effusion	22.2% 6/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Productive cough	14.8% 4/27 • Number of events 4 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	14.8% 4/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Rales	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Tachypnoea	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Respiratory, thoracic and mediastinal disorders Wheezing	29.6% 8/27 • Number of events 8 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Ecchymosis	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Night sweats	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Petechiae	7.4% 2/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Pruritus	37.0% 10/27 • Number of events 12 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Rash	18.5% 5/27 • Number of events 7 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Skin ulcer	18.5% 5/27 • Number of events 5 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Skin and subcutaneous tissue disorders Urticaria	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Surgical and medical procedures Wound drainage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Deep vein thrombosis	11.1% 3/27 • Number of events 3 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Haematoma	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Haemorrhage	7.4% 2/27 • Number of events 2 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Hypertension	59.3% 16/27 • Number of events 17 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
Vascular disorders Hypotension	29.6% 8/27 • Number of events 15 • From transplantation until study completion or participant termination (participants followed up to 48 months post-transplantation) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)

Additional Information

Associate Director, Clinical Research Program

DAIT/NIAID

Phone: 301-594-7669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place