Trial Outcomes & Findings for Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (NCT NCT02533180)
NCT ID: NCT02533180
Last Updated: 2023-09-14
Results Overview
Participants are considered as successfully withdrawn from immunosuppression if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria. This biopsy is assessed by the central pathologist. All participants who fail to complete immunosuppression withdrawal, regardless of reason, or fail to have a biopsy 52 weeks after completion of immunosuppression withdrawal will be considered to have failed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From initiation of immunosuppression withdrawal through 52 weeks after stopping all immunosuppression
Results posted on
2023-09-14
Participant Flow
100 participants were enrolled from 7 sites in the US between December 2015 and November 2018. 61 of the enrolled participants were eligible to initiate immunosuppression withdrawal and the remaining 39 participants were terminated (e.g., ineligible to initiate immunosuppression withdrawal) based on biopsy findings or other pre-specified criteria.
Informed consent was obtained from potentially eligible individuals who then underwent a study-mandated biopsy to determine if they were allowed to initiate immunosuppression withdrawal based on pre-specified histological criteria.
Participant milestones
| Measure |
Enrolled, Did Not Initiate Immunosuppression Withdrawal
Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
|
Initiated Immunosuppression Withdrawal
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
61
|
|
Overall Study
COMPLETED
|
0
|
50
|
|
Overall Study
NOT COMPLETED
|
39
|
11
|
Reasons for withdrawal
| Measure |
Enrolled, Did Not Initiate Immunosuppression Withdrawal
Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
|
Initiated Immunosuppression Withdrawal
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Screen Failure
|
37
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
Baseline Characteristics
Only participants that initiated immunosuppression withdrawal will have both measurements.
Baseline characteristics by cohort
| Measure |
Enrolled, Did Not Initiate Immunosuppression Withdrawal
n=39 Participants
Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
|
Initiated Immunosuppression Withdrawal
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=39 Participants
|
37 Participants
n=61 Participants
|
68 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=39 Participants
|
24 Participants
n=61 Participants
|
32 Participants
n=100 Participants
|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 15.88 • n=39 Participants
|
60.3 years
STANDARD_DEVIATION 12.07 • n=61 Participants
|
56.7 years
STANDARD_DEVIATION 14.35 • n=100 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=39 Participants
|
18 Participants
n=61 Participants
|
33 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=39 Participants
|
43 Participants
n=61 Participants
|
67 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
4 Participants
n=61 Participants
|
6 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=39 Participants
|
49 Participants
n=61 Participants
|
85 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
8 Participants
n=61 Participants
|
9 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=61 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
6 Participants
n=61 Participants
|
7 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=39 Participants
|
1 Participants
n=61 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
0 Participants
n=61 Participants
|
2 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=39 Participants
|
50 Participants
n=61 Participants
|
83 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
1 Participants
n=61 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=61 Participants
|
5 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=39 Participants
|
61 Participants
n=61 Participants
|
100 Participants
n=100 Participants
|
|
Alanine Transaminase (ALT)
|
—
|
23.8 U/L
STANDARD_DEVIATION 10.7 • n=61 Participants • Only participants that initiated immunosuppression withdrawal will have both measurements.
|
23.8 U/L
STANDARD_DEVIATION 10.7 • n=61 Participants • Only participants that initiated immunosuppression withdrawal will have both measurements.
|
|
Gamma-glutamyl Transferase (GGT)
|
—
|
34.2 U/L
STANDARD_DEVIATION 24.58 • n=61 Participants • Only participants that initiated immunosuppression withdrawal will have both measurements.
|
34.2 U/L
STANDARD_DEVIATION 24.58 • n=61 Participants • Only participants that initiated immunosuppression withdrawal will have both measurements.
|
|
Time from transplant (years)
|
11.5 Years
STANDARD_DEVIATION 7.99 • n=39 Participants
|
9.1 Years
STANDARD_DEVIATION 5.65 • n=61 Participants
|
10.0 Years
STANDARD_DEVIATION 6.73 • n=100 Participants
|
|
Estimated Glomerular filtration rate (eGFR)
|
—
|
73.9 mL/min/1.73 m2
STANDARD_DEVIATION 17.66 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
73.9 mL/min/1.73 m2
STANDARD_DEVIATION 17.66 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Fibrosis Score (ISHAK)
0
|
—
|
49.2 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
49.2 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Fibrosis Score (ISHAK)
1
|
—
|
44.3 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
44.3 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Fibrosis Score (ISHAK)
2
|
—
|
6.6 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
6.6 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Liver Allograft Function Score (LAFSc)
0
|
—
|
27.9 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
27.9 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Liver Allograft Function Score (LAFSc)
1
|
—
|
34.4 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
34.4 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Liver Allograft Function Score (LAFSc)
2
|
—
|
19.7 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
19.7 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Liver Allograft Function Score (LAFSc)
3
|
—
|
13.1 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
13.1 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
Liver Allograft Function Score (LAFSc)
4
|
—
|
4.9 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
4.9 Percent of participants
n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
NIDDK Liver Transplantation Database Quality of Life
Measures of disease domain
|
—
|
7.4 NIDDK QOL Score
STANDARD_DEVIATION 4.57 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
7.4 NIDDK QOL Score
STANDARD_DEVIATION 4.57 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
|
NIDDK Liver Transplantation Database Quality of Life
Psychological status domain
|
—
|
2.1 NIDDK QOL Score
STANDARD_DEVIATION 1.68 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
2.1 NIDDK QOL Score
STANDARD_DEVIATION 1.68 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
|
NIDDK Liver Transplantation Database Quality of Life
Personal function domain
|
—
|
2.6 NIDDK QOL Score
STANDARD_DEVIATION 1.37 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
2.6 NIDDK QOL Score
STANDARD_DEVIATION 1.37 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
|
NIDDK Liver Transplantation Database Quality of Life
Social and role function domain
|
—
|
4.1 NIDDK QOL Score
STANDARD_DEVIATION 3.00 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
4.1 NIDDK QOL Score
STANDARD_DEVIATION 3.00 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
|
NIDDK Liver Transplantation Database Quality of Life
General health perception domain
|
—
|
8.1 NIDDK QOL Score
STANDARD_DEVIATION 1.48 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
8.1 NIDDK QOL Score
STANDARD_DEVIATION 1.48 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement
|
|
SF-36
PCS
|
—
|
49.5 SF-36 Component Score
STANDARD_DEVIATION 9.05 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
49.5 SF-36 Component Score
STANDARD_DEVIATION 9.05 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
|
SF-36
MCS
|
—
|
53.8 SF-36 Component Score
STANDARD_DEVIATION 8.14 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
53.8 SF-36 Component Score
STANDARD_DEVIATION 8.14 • n=61 Participants • Only subjects that initiated immunosuppression withdrawal will have this measurement.
|
PRIMARY outcome
Timeframe: From initiation of immunosuppression withdrawal through 52 weeks after stopping all immunosuppressionPopulation: Participants who initiated immunosuppression withdrawal
Participants are considered as successfully withdrawn from immunosuppression if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria. This biopsy is assessed by the central pathologist. All participants who fail to complete immunosuppression withdrawal, regardless of reason, or fail to have a biopsy 52 weeks after completion of immunosuppression withdrawal will be considered to have failed.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Percent of Participants Who Achieve Operational Tolerance 52 Weeks After Completion of Immunosuppression Withdrawal.
|
16.4 Percent of Participants
Interval 8.15 to 28.1
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Initiated immunosuppression withdrawal and have analyzable blood samples prior to and after initiating withdrawal
HLA is a molecule formed by a complex of genes which encode cell-surface proteins responsible for the regulation of the immune system. This molecule is unique for each individual. HLA molecules are present in all cells and are responsible for helping the immune system distinguish between your own cells and foreign cells (like pathogens). However, when our immune system encounters HLA molecules from another individual (like during pregnancy, after blood transfusions or transplantation) it recognizes this as foreign and can generate anti-HLA antibodies. These anti-HLA antibodies could cause harm to the transplanted organ by recognizing its cells as foreign triggering the immune system to attack. This endpoint looks at the development of newly developed donor-specific antibodies (DSA). DSA are a subset of anti-HLA antibodies that are specific against the donor organ. These anti-HLA antibodies are categorized into two classes-class I and class II. The data shown is only for class II DSA.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=52 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Proportion of Participants Who Develop Donor-Specific AlloAbs (DSA) or de Novo Anti-human Leukocyte Antigen Human Leukocyte Antigen (HLA) Antibodies
|
26.9 Percent of participants
Interval 15.57 to 41.02
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
Incidence will be measured as the proportion of participants who have acute rejection (per Banff criteria), steroid resistant rejection (rejection requiring antibody treatment), and chronic rejection (per Banff criteria), separately. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Incidence of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Acute Rejection
|
47.5 Percent of participants
Interval 34.6 to 60.73
|
—
|
|
The Incidence of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Steroid Resistant Rejection
|
0 Percent of participants
Interval 0.0 to 5.87
|
—
|
|
The Incidence of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Chronic Rejection
|
0 Percent of participants
Interval 0.0 to 5.87
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who had acute, steroid-resistant, or chronic rejection.
Severity is based on the Banff global assessment grade according to the central pathology reading of the liver biopsy. For an individual subject, the worst severity is reported. Acute rejection is categorized into mild (rejection infiltrate in a minority of triads that is generally mild and confined within the portal spaces), moderate (rejection infiltrate expanding most or all of the triads), or severe (rejection infiltrate expanding most or all of the triads with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis). Chronic rejection is categorized into early (bile duct atrophy/loss and foam cell obliterative arteriopathy in \<50% of the portal tracts) or late (early criteria but \>50% of the portal tracts) stage. Steroid resistant rejection is always considered severe. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=29 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Acute Rejection, Mild
|
75.9 Percent of participants
Interval 56.46 to 89.7
|
—
|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Acute Rejection, Moderate
|
20.7 Percent of participants
Interval 7.99 to 39.72
|
—
|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Acute Rejection, Severe
|
3.5 Percent of participants
Interval 0.09 to 17.76
|
—
|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Chronic Rejection, Early Stage
|
0 Percent of participants
Interval 0.0 to 11.94
|
—
|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Chronic Rejection, Late Stage
|
0 Percent of participants
Interval 0.0 to 11.94
|
—
|
|
The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Steroid Resistant Rejection
|
0 Percent of participants
Interval 0.0 to 11.94
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who had acute, steroid-resistant, or chronic rejection.Time to event data could not be reported as no events were observed for Chronic Rejection and Steroid Resistant Rejection
Time is measured as the time (in days) from the initiation of immunosuppression withdrawal to the time of the first biopsy showing rejection (per Banff criteria).
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=29 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Timing of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
The Timing of Acute Rejection
|
232 Days
Standard Deviation 134.5
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal.
Fibrosis of the liver is the formation of an excessive accumulation of scar tissue in the liver. Graft fibrosis was measured two ways by the ISHAK scale and by Liver Allograft Fibrosis Score (LAFSc) via a liver biopsy. Both scales range from 0 to 6, with a higher score indicating more severe fibrosis. A subject is considered as having graft fibrosis if the score is greater than or equal to 2 at their last available biopsy after the initiation of immunosuppression withdrawal.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=10 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
n=41 Participants
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Incidence of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients.
ISHAK
|
0 Percent of participants
Interval 0.0 to 30.85
|
12.2 Percent of participants
Interval 4.08 to 26.2
|
|
The Incidence of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients.
Liver Allograft Fibrosis Score
|
50.0 Percent of participants
Interval 18.71 to 81.29
|
48.8 Percent of participants
Interval 32.88 to 64.87
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal.
Fibrosis of the liver is the formation of an excessive accumulation of scar tissue in the liver. Graft fibrosis was measured two ways by the ISHAK scale and by Liver Allograft Fibrosis Score (LAFSc) via a liver biopsy. Both scales range from 0 to 6, with a higher score indicating more severe fibrosis. Progression was calculated as the final available biopsy score minus the baseline biopsy score. A positive value indicates a worsening of fibrosis.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=10 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
n=41 Participants
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Progression of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients
ISHAK
|
0 Fibrosis Score
Standard Deviation 0.94
|
0.2 Fibrosis Score
Standard Deviation 0.79
|
|
The Progression of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients
Liver Allograft Fibrosis Score
|
0.1 Fibrosis Score
Standard Deviation 1.73
|
0.3 Fibrosis Score
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
A participant is considered to have graft loss when the donated liver needs to be removed and the participant is retransplanted with another donor liver or the participant is listed for retransplant. The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Incidence of Graft Loss
|
0 Percent of participants
Interval 0.0 to 5.87
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
This number reflects all deaths observed in all participants in the study period, regardless of the cause. The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Incidence of All-Cause Mortality
|
3.3 Percent of participants
Interval 0.4 to 11.35
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
An adverse event is considered a serious adverse event (SAE) if it results it any one of the following: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substation disruption to conduct normal life functions, congenital anomaly or birth defect, or an important medical event. The event is considered study related if the medical monitor deems it to be at least possibly or definitely related to any of the study interventions/procedures (immunosuppression withdrawal, the blood draw, or the liver biopsy). The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Incidence of Study-related SAEs
|
16.4 Percent of participants
Interval 8.15 to 28.09
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal through 3 years after completing immunosuppression withdrawal.Population: Participants who achieved operational tolerance as defined by the primary endpoint.
Participants are considered operationally tolerant if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria (as assessed by the central pathologist). This number reflects the participants that continue to show the absence of rejection per the Banff global assessment criteria (as assessed by the central pathologist) in the 3 years following completion of immunosuppression withdrawal. The endpoint will be summarized with a two-sided, 95% exact binomial confidence interval.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=10 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
The Proportion of Operationally Tolerant Subjects Who Remain Free of Rejection at 3 Years After Completing Immunosuppression Withdrawal.
|
100 Percent of participants
Interval 69.15 to 100.0
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
Glomerular filtration rate (GFR) is a measure of kidney function and helps determine the stage of kidney disease. A value less than 15 indicates kidney failure, 15 to 29 indicates severe loss of kidney function, 30 to 44 indicates moderate to severe loss of kidney function, 45 to 59 mild to moderate loss of kidney function, 60 to 89 indicates mild loss of kidney function, and 90 or higher indicates normal kidney function. The equation developed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) is used to estimate GFR from serum creatinine. The baseline value was selected as the value collected immediately prior to the initiation of immunosuppression withdrawal. The year 1, 2, and 3, values are the values closest to and within 2 months of the expected date. Change was calculated as the year 1, 2, or 3 value minus baseline. A positive value indicates an increase in kidney function.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=10 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
n=51 Participants
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Changes in Renal Function (Defined as Estimated GFR Calculated by the CKD-EPI Creatine Equation 2021) in Tolerant Versus Non-tolerant Participants at 1, 2 and 3 Years After Completing Immunosuppression Withdrawal.
1 Yeaar
|
4.8 ml/min/1.73 m^2
Standard Deviation 13.67
|
0 ml/min/1.73 m^2
Standard Deviation 13.85
|
|
Changes in Renal Function (Defined as Estimated GFR Calculated by the CKD-EPI Creatine Equation 2021) in Tolerant Versus Non-tolerant Participants at 1, 2 and 3 Years After Completing Immunosuppression Withdrawal.
2 Years
|
4.2 ml/min/1.73 m^2
Standard Deviation 21.32
|
-4.0 ml/min/1.73 m^2
Standard Deviation 12.19
|
|
Changes in Renal Function (Defined as Estimated GFR Calculated by the CKD-EPI Creatine Equation 2021) in Tolerant Versus Non-tolerant Participants at 1, 2 and 3 Years After Completing Immunosuppression Withdrawal.
3 year
|
-2.8 ml/min/1.73 m^2
Standard Deviation 18.11
|
-2.6 ml/min/1.73 m^2
Standard Deviation 13.85
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal and completed a NIDDK Liver Transplantation Database Quality of Life survey at baseline and after immunosuppression withdrawal initiation.
NIDDK Liver Transplantation Database Quality of Life Form is a patient-reported survey of patient health. The questionnaire is summarized into five domains-measures of disease (ranges from 0-21 with higher score indicating worse quality), psychological status (ranges from 0-5 with higher score indicating worse quality), personal function (ranges from 0-4 with higher score indicating better quality), social and role function (ranges from 0 to 20 with higher score indicating worse quality), and general health perception (ranges from 0 to 10 with higher score indicating better quality). Change was calculated as the difference between the questionnaire completed at the initiation of withdrawal and the questionnaire completed closest to the end of study participation. This change was calculated separately for tolerant and non-tolerant subjects.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=9 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
n=47 Participants
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation, as Measured by the NIDDK Liver Transplantation Database Quality of Life Form.
Psychological status domain
|
-0.6 Domain Score
Standard Deviation 2.07
|
0.2 Domain Score
Standard Deviation 1.43
|
|
Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation, as Measured by the NIDDK Liver Transplantation Database Quality of Life Form.
Personal function domain
|
0.1 Domain Score
Standard Deviation 1.73
|
-0.2 Domain Score
Standard Deviation 1.14
|
|
Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation, as Measured by the NIDDK Liver Transplantation Database Quality of Life Form.
Measures of disease domain
|
-1.9 Domain Score
Standard Deviation 5.69
|
0.5 Domain Score
Standard Deviation 4.31
|
|
Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation, as Measured by the NIDDK Liver Transplantation Database Quality of Life Form.
Social and role function domain
|
1.7 Domain Score
Standard Deviation 2.89
|
1.1 Domain Score
Standard Deviation 2.92
|
|
Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation, as Measured by the NIDDK Liver Transplantation Database Quality of Life Form.
General health perception domain
|
-0.8 Domain Score
Standard Deviation 2.11
|
-0.5 Domain Score
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal and completed a SF-36 survey at baseline and after immunosuppression withdrawal initiation.
SF-36 is a patient-reported survey of patient health. There are eight different scales that can be summarized into two summary scores-Mental Component Score and Physical Component Score. Each score ranges from 0-100, with a higher score indicating a better quality of life. Change was calculated as the difference between the questionnaire completed at the initiation of withdrawal and the questionnaire completed closest to the end of study participation. This change was calculated separately for tolerant and non-tolerant subjects.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=9 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
n=45 Participants
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Changes in SF-36 in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation.
Physical Component Score
|
-3.4 SF-36 Component Score
Standard Deviation 8.75
|
-1.9 SF-36 Component Score
Standard Deviation 7.72
|
|
Changes in SF-36 in Tolerant Versus Non-tolerant Participants and in All Participants at Baseline Versus the End of Study Participation.
Mental Component Score
|
0.5 SF-36 Component Score
Standard Deviation 9.75
|
-0.7 SF-36 Component Score
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
Time post-transplant is calculated as time in years from transplant to enrollment. Participants are considered operationally tolerant if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria (as assessed by the central pathologist). The odds ratio and corresponding 95% confidence interval are presented. The odds ratio represents the probability of achieving operational tolerance per year increase in time post-transplant. An odds ratio greater than 1 means that as the factor increases, operational tolerance is more likely to occur. Whereas less than 1 means operational tolerance is less likely to occur. Since the confidence interval contains 1, this means that as the corresponding factor increases, the likelihood of tolerance does not change.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Predictive Value of the Following Parameters With Regard to Operational Tolerance: Time Post-transplant.
|
0.994 Probability of operational tolerance
Interval 0.864 to 1.144
|
—
|
SECONDARY outcome
Timeframe: From initiation of immunosuppression withdrawal to study completion, up to 4.5 years.Population: Participants who initiated immunosuppression withdrawal
Recipient age is the age at the time of enrollment. Participants are considered operationally tolerant if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria (as assessed by the central pathologist). The odds ratio and corresponding 95% confidence interval are presented. The odds ratio represents the probability of achieving operational tolerance per year increase in recipient age. An odds ratio greater than 1 means that as the factor increases, operational tolerance is more likely to occur. Whereas less than 1 means operational tolerance is less likely to occur. Since the confidence interval contains 1, this means that as the corresponding factor increases, the likelihood of tolerance does not change.
Outcome measures
| Measure |
Immunosuppression Withdrawal (ISW)
n=61 Participants
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
Initiated Immunosuppression Withdrawal With Available Biopsy (Non-tolerant)
Participants who initiated immunosuppression withdrawal and have a biopsy available after the initiation of immunosuppression withdrawal and deemed non-tolerant by the primary endpoint.
|
|---|---|---|
|
Predictive Value and the Correlative Value of the Following Parameters With Regard to Operational Tolerance: Recipient Age.
|
0.982 Probability of operational tolerance
Interval 0.922 to 1.045
|
—
|
Adverse Events
Enrolled, Did Not Initiate Immunosuppression Withdrawal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Initiated Immunosuppression Withdrawal
Serious events: 27 serious events
Other events: 53 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Enrolled, Did Not Initiate Immunosuppression Withdrawal
n=39 participants at risk
Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
|
Initiated Immunosuppression Withdrawal
n=61 participants at risk
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Eye disorders
Diplopia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 7 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Gait disturbance
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Intrahepatic portal hepatic venous fistula
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
8.2%
5/61 • Number of events 6 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Viral infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Blood glucose increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Cardiac murmur
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Migraine
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Syncope
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Chest Pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
Other adverse events
| Measure |
Enrolled, Did Not Initiate Immunosuppression Withdrawal
n=39 participants at risk
Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol.
|
Initiated Immunosuppression Withdrawal
n=61 participants at risk
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
|
|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
8.2%
5/61 • Number of events 6 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Blood glucose increased
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Cardiac murmur
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/39 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
8.2%
5/61 • Number of events 5 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Eye disorders
Diplopia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/39 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Gait disturbance
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Haemobilia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Hepatobiliary disorders
Intrahepatic portal hepatic venous fistula
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
45.9%
28/61 • Number of events 28 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 4 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Influenza
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Post procedural cellulitis
|
2.6%
1/39 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
6.6%
4/61 • Number of events 4 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
9.8%
6/61 • Number of events 6 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
8.2%
5/61 • Number of events 6 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Viral infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
8.2%
5/61 • Number of events 5 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/39 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
4.9%
3/61 • Number of events 3 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Migraine
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Syncope
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
3.3%
2/61 • Number of events 2 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
1.6%
1/61 • Number of events 1 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
General disorders
Chest pain
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/39 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
0.00%
0/61 • Up to 4.5 years
Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place