Trial Outcomes & Findings for Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients (NCT NCT00320606)

NCT ID: NCT00320606

Last Updated: 2018-09-20

Results Overview

Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 year after completion of immunosuppression withdrawal
• Results posted on: 2018-09-20

Participant Flow

Three centers in the United States enrolled 20 pediatric recipients of parental living-donor liver allografts between June 2006 and August 2008.

Informed consent was obtained from eligible individuals prior to screening assessments. Participants then underwent procedures at screening to determine eligibility according to the study's inclusion/exclusion criteria.

Participant milestones

Measure	Immunosuppression Withdrawal Arm Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Immunosuppression Withdrawal Arm Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Overall Study Adverse Event	1
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients

Baseline characteristics by cohort

Measure	Immunosuppression Withdrawal Arm n=20 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Age, Categorical <=18 years	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	8.7 Years STANDARD_DEVIATION 2.96 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
Baseline Glomerular Filtration Rate (GFR)	113.2 mL/min/1.73 m^2 n=5 Participants
Baseline Total Cholesterol	147 mg/dL n=5 Participants
Baseline Glucose	89.5 mg/dL n=5 Participants
Baseline Systolic Blood Pressure	109.5 mmHg n=5 Participants
Baseline Diastolic Blood Pressure	64.5 mmHg n=5 Participants

PRIMARY outcome

Timeframe: 1 year after completion of immunosuppression withdrawal

Population: Intent-to-Treat

Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=20 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Proportion of Participants Successfully Withdrawn From Immunosuppression	0.60 Proportion of participants

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-to-Treat

Participants who died while on the study for any reason as well as participants that experienced the loss of their transplant while a participant in the study.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=20 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal	0 Participants

SECONDARY outcome

Timeframe: From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years)

Population: Intent-to-Treat participants who experienced acute rejection or were diagnosed with chronic rejection.

The number of days between the start of immunosuppression (IS) withdrawal and the first episode of acute rejection (either clinical rejection or based on BANFF criteria), second episode of rejection that did not require treatment, or the first diagnosis of chronic rejection.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=7 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection	211.57 Days Interval 113.56 to 309.58

SECONDARY outcome

Timeframe: Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression

Population: Intent-to-Treat participants who completed withdrawal

The number of months between the end of immunosuppression withdrawal and either the end of trial participation or the time of restarting immunosuppression

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=15 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Immunosuppression-Free Duration	75.84 Months Interval 53.28 to 98.39

SECONDARY outcome

Timeframe: Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years)

Population: Participants from the Intent-to-treat group who experienced a biopsy-proven rejection episode

The number of participants within each level of histologic severity based on BANFF grading criteria (Mild, Moderate, Severe).

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=4 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Distribution of Histologic Severity Among Rejection Episodes Mild	3 Biopsy Proven rejection episodes
Distribution of Histologic Severity Among Rejection Episodes Moderate	2 Biopsy Proven rejection episodes
Distribution of Histologic Severity Among Rejection Episodes Severe	0 Biopsy Proven rejection episodes

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-To-Treat

The results provide the total number of participants experiencing adverse events (AEs). Participants experiencing AEs are stratified into five severity categories: mild, moderate, severe, life-threatening, and death, based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=20 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Number of Participants Experiencing Adverse Events by Severity Mild	18 Participants
Number of Participants Experiencing Adverse Events by Severity Total Adverse Events	19 Participants
Number of Participants Experiencing Adverse Events by Severity Moderate	17 Participants
Number of Participants Experiencing Adverse Events by Severity Severe	6 Participants
Number of Participants Experiencing Adverse Events by Severity Life Threatening	0 Participants
Number of Participants Experiencing Adverse Events by Severity Death	0 Participants

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-To-Treat with GFR data at visits available for analysis

Percent change from baseline at each annual visit. The bedside Schwartz equation was used to estimate GFR from serum creatinine and height in children. Baseline serum creatinine was utilized in the equation, defined as the creatinine value at the start of IS tapering. Baseline height was utilized in the equation, defined as the last height recorded prior to the start of IS tapering. Serum creatinine measurements and height measurements at the annual visits were used to calculate the annual GFR. When height value was not available, the height collected prior to the annual visit was used in the GFR calculation. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=18 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at Month 12	4.5 Percent change Interval 2.41 to 22.42
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at M12 Visit	8.7 Percent change Interval 3.89 to 28.05
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at M24 Visit	20.5 Percent change Interval 5.46 to 48.4
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at L12 Visit	10.8 Percent change Interval -1.71 to 34.89
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at L24 Visit	7.3 Percent change Interval -7.86 to 38.84
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at E12 Visit	-3.9 Percent change Interval -9.97 to 31.52
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at E24 Visit	-6.3 Percent change Interval -22.18 to 23.66
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at E36 Visit	-5.1 Percent change Interval -15.76 to 15.2
Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) Percent Change in GFR at E48 Visit	-15.1 Percent change Interval -23.38 to 2.13

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-To-Treat with cholesterol data available at visit

Percent change from baseline in total serum cholesterol. Cholesterol is a waxy substance your body needs to build cells, but too much can be a problem since it can build-up in arteries. Narrowed arteries can result in heart attack or stroke. This outcome looks at the percent change from baseline (cholesterol level at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=13 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at Month 12	-7.9 Percent change Interval -16.23 to -5.33
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at M12 Visit	-0.6 Percent change Interval -9.74 to 4.07
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at M24 Visit	-10.9 Percent change Interval -14.21 to -5.92
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at L12 Visit	-3.0 Percent change Interval -16.67 to 1.26
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at L24 Visit	-10.7 Percent change Interval -18.37 to -7.1
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at E12 Visit	-9.0 Percent change Interval -15.38 to 0.94
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at E24 Visit	-11.2 Percent change Interval -15.38 to -5.66
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at E36 Visit	-6.9 Percent change Interval -19.0 to 6.78
Percent Change From Baseline in Total Cholesterol Percent Change in Cholesterol at E48 Visit	-10.9 Percent change Interval -14.51 to 10.36

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-To-Treat with glucose data available at visit

Glucose, a sugar, is an energy source that the body relies on to properly function. If levels are too high for a long period of time, diabetes can develop. Diabetes can result in many long-term complications such as eye, kidney, and nerve damage, stroke, and cardiovascular complications. The outcome looks at the percent change from baseline (glucose level at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=17 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at Month 12	-2.2 Percent change Interval -4.44 to 10.87
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at M12 Visit	1.0 Percent change Interval -6.32 to 13.41
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at M24 Visit	1.8 Percent change Interval -5.47 to 9.41
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at L12 Visit	-0.5 Percent change Interval -5.42 to 9.09
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at L24 Visit	2.0 Percent change Interval 0.0 to 15.22
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at E12 Visit	-3.3 Percent change Interval -7.53 to 8.99
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at E24 Visit	-1.1 Percent change Interval -6.45 to 4.82
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at E36 Visit	5.6 Percent change Interval -5.32 to 13.98
Percent Change From Baseline in Blood Glucose Percent Change in Glucose at E48 Visit	-5.3 Percent change Interval -10.64 to 4.49

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-to-treat with systolic blood pressure data available at visit

Systolic blood pressure (BP) measures the pressure on the blood vessels when the heart is beats and thus is pushing blood to the rest of the body. This outcome assesses the percent change from baseline (systolic blood pressure measurement at the start of tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=17 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at E48 Visit	2.7 Percent change Interval -4.17 to 13.76
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at Month 12	2.0 Percent change Interval -9.65 to 6.32
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at M12 Visit	0.0 Percent change Interval -9.65 to 5.83
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at M24	4.3 Percent change Interval -2.87 to 10.66
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at L12 Visit	3.8 Percent change Interval -5.05 to 10.08
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at L24 Visit	8.6 Percent change Interval 2.68 to 20.41
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at E12 Visit	2.8 Percent change Interval -4.46 to 14.53
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at E24 Visit	5.1 Percent change Interval -3.23 to 11.67
Percent Change From Baseline in Systolic Blood Pressure Percent Change in Systolic BP at E36 Visit	9.2 Percent change Interval 0.92 to 12.82

SECONDARY outcome

Timeframe: Enrollment through end of study (up to 9.5 years)

Population: Intent-to-treat with diastolic blood pressure data available at visit

Diastolic blood pressure (BP) measures the pressure in the arteries when the heart is a rest and is thus filled with blood. This outcome assesses the percent change from baseline (diastolic blood pressure measurement at the start of IS tapering) to each annual visit. M12 and M24 visits represent Medium Frequency visits; L12 and L24 represent low frequency visits, and E12-48 represent extended follow-up visits.

Outcome measures

Measure	Immunosuppression Withdrawal Arm n=17 Participants Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at Month 12	-7.5 Percent change Interval -15.38 to 7.41
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP atM12 Visit	0.0 Percent change Interval -8.22 to 2.7
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at M24 Visit	-5.4 Percent change Interval -16.41 to 11.92
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at L12 Visit	1.5 Percent change Interval -12.41 to 4.73
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at L24 Visit	6.6 Percent change Interval -9.59 to 7.59
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at E12 Visit	0.0 Percent change Interval -7.14 to 6.06
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at E24 Visit	2.6 Percent change Interval -5.33 to 4.55
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at E36 Visit	-1.4 Percent change Interval -8.22 to 6.58
Percent Change From Baseline in Diastolic Blood Pressure Percent Change in Diastolic BP at E48	9.1 Percent change Interval -7.89 to 11.11

Adverse Events

Immunosuppression Withdrawal Arm

Serious events: 13 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Immunosuppression Withdrawal Arm n=20 participants at risk Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Gastrointestinal disorders Abdominal pain	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Vomiting	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Bile duct obstruction	5.0% 1/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Bile duct stenosis	15.0% 3/20 • Number of events 5 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Cholangitis	5.0% 1/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Cholangitis acute	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Cholelithiasis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Hepatitis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Portal vein stenosis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Immune system disorders Transplant rejection	25.0% 5/20 • Number of events 5 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Enterococcal bacteraemia	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Gastritis viral	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Influenza	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Klebsiella infection	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Liver function test abnormal	15.0% 3/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Diaphragmatic hernia	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Surgical and medical procedures Ventricular septal defect repair	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.

Other adverse events

Measure	Immunosuppression Withdrawal Arm n=20 participants at risk Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Blood and lymphatic system disorders Splenomegaly	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Ear and labyrinth disorders Cerumen impaction	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Ear and labyrinth disorders Ear pain	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Eye disorders Conjunctivitis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Abdominal pain upper	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Constipation	25.0% 5/20 • Number of events 6 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Diarrhoea	5.0% 1/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Mouth ulceration	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Gastrointestinal disorders Vomiting	15.0% 3/20 • Number of events 4 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
General disorders Influenza like illness	45.0% 9/20 • Number of events 35 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
General disorders Pyrexia	20.0% 4/20 • Number of events 5 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Bile duct stenosis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Hepatobiliary disorders Cholangitis	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Immune system disorders Immunisation reaction	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Bronchitis	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Ear infection	15.0% 3/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Fungal skin infection	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Gastroenteritis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Impetigo	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Influenza	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Nasopharyngitis	10.0% 2/20 • Number of events 5 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Oral herpes	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Pertussis	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Pharyngitis streptococcal	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Pneumonia	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Rhinitis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Sinusitis	30.0% 6/20 • Number of events 9 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Streptococcal infection	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Tonsillitis	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Upper respiratory tract infection	20.0% 4/20 • Number of events 4 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Urinary tract infection	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Varicella	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Vulvovaginal mycotic infection	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Infections and infestations Wound infection	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Animal bite	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Arthropod bite	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Concussion	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Graft dysfunction	5.0% 1/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Mouth injury	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Muscle strain	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Suture related complication	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Upper limb fracture	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Injury, poisoning and procedural complications Wrist fracture	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Alanine aminotransferase increased	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Aspartate aminotransferase increased	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Blood alkaline phosphatase increased	5.0% 1/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Blood magnesium decreased	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Gamma-glutamyltransferase increased	15.0% 3/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Hepatic enzyme increased	25.0% 5/20 • Number of events 10 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Liver function test abnormal	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Smooth muscle antibody positive	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Spleen palpable	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Investigations Vitamin D decreased	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Metabolism and nutrition disorders Decreased appetite	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Musculoskeletal and connective tissue disorders Growing pains	5.0% 1/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Musculoskeletal and connective tissue disorders Synovial cyst	5.0% 1/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Nervous system disorders Headache	20.0% 4/20 • Number of events 4 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Nervous system disorders Migraine	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Psychiatric disorders Anxiety	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Psychiatric disorders Depression	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Reproductive system and breast disorders Dysmenorrhoea	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Reproductive system and breast disorders Scrotal varicose veins	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Cough	35.0% 7/20 • Number of events 11 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 4/20 • Number of events 6 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Sinus congestion	20.0% 4/20 • Number of events 6 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Acanthosis nigricans	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Acne	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Dermal cyst	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Dermatitis contact	10.0% 2/20 • Number of events 3 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Dry skin	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Eczema	10.0% 2/20 • Number of events 2 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Rash	15.0% 3/20 • Number of events 4 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Skin and subcutaneous tissue disorders Urticaria	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.
Vascular disorders Hypertension	5.0% 1/20 • Number of events 1 • Enrollment through end of study (up to 9.5 years) Total number of participants in the Immunosuppression (IS) Withdrawal Arm experiencing adverse events. Participants experiencing adverse events are broken down into five severity categories, mild, moderate, severe, life-threatening, and death based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 3.0.

Additional Information

Director, Clinical Research Program

DAIT/NIAID

Phone: 301-594-7669

Email: DAITClinicalTrialsgov@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place