Trial Outcomes & Findings for Regimen Optimization Study (NCT NCT02137239)
NCT ID: NCT02137239
Last Updated: 2021-06-22
Results Overview
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
6 Months
Results posted on
2021-06-22
Participant Flow
58 participants randomized and treated
Participant milestones
| Measure |
Treatment A
BELA + EVL
|
Treatment B
TAC + MMF
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
32
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Treatment A
BELA + EVL
|
Treatment B
TAC + MMF
|
|---|---|---|
|
Overall Study
Discontinued Study Treatment
|
0
|
3
|
|
Overall Study
Withdrew Consent
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Regimen Optimization Study
Baseline characteristics by cohort
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
51.7 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
50.8 Years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
51.2 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Age, Customized
< 65
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Customized
≥ 65
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: ITT Population
Number of Participants with Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6 Months
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6 Months
|
7.7 Percentage of participants
Interval 0.9 to 25.1
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Clinically-suspected biopsy-proven acute rejection (CSBPAR) at 6, 12 and 24 Months Change in the incidence of CSBPAR at 6, 12 and 24 months post transplant, in the belatacept + EVL(Treatment A) as compared to TAC + MMF (Treatment B).
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
CSBPAR at 12 months
|
11.5 Percentage of CSBPAR
Interval 2.4 to 30.2
|
12.5 Percentage of CSBPAR
Interval 3.5 to 29.0
|
|
Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
CSBPAR at 24 Months
|
15.4 Percentage of CSBPAR
Interval 4.4 to 34.9
|
12.5 Percentage of CSBPAR
Interval 3.5 to 29.0
|
|
Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR) at 6, 12 and 24 Months
CSBPAR at 6 Months
|
7.7 Percentage of CSBPAR
Interval 0.9 to 25.1
|
9.4 Percentage of CSBPAR
Interval 2.0 to 25.0
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: Participants with a CSBPAR
Time to Clinically suspected biopsy proven acute rejection
Outcome measures
| Measure |
Treatment A
n=3 Participants
BELA + EVL
|
Treatment B
n=3 Participants
TAC + MMF
|
|---|---|---|
|
Time to Clinically-suspected Biopsy-proven Acute Rejection (CSBPAR).
|
NA Months
Randomization Error: See limitations and caveats
|
NA Months
Randomization Error: See limitations and caveats
|
SECONDARY outcome
Timeframe: At 6, 12 and 24 MonthsPopulation: ITT Population
Treatment differences in the severity grades to treat all episodes of CSBPAR at 6, 12, and 24 months post-transplant. Type 1A - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>4 mononuclear cells/Tubular cross section or group of 10 Tubular cell). Type 1B - Cases with significant interstitial infiltration (\>25% of parenchyma affected) and foci of moderate tubulitis (\>10 mononuclear cells/Tubular cross section or group of 10 Tubular cell).Type 2A - Cases with mild to moderate intimal arteritis.Type 2B - Cases with severe intimal arteritis comprising \>25% of the luminal area. Type 3 - Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (v3 with accompanying lymphocytic inflammation)
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
6 Months: Severe Acute
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
24 Months: Mild Acute (1B)
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
6 Months: Mild Acute (1A)
|
3.8 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
6 Months: Mild Acute (1B)
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
6 Months: Moderate Acute (2A)
|
7.7 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
6 Months: Moderate Acute (2B)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
12 Months: Mild Acute (1A)
|
7.7 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
12 Months: Mild Acute (1B)
|
0 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
12 Months: Moderate Acute (2A)
|
7.7 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
12 Months: Moderate Acute (2B)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
12 Months: Severe Acute
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
24 Months: Mild Acute (1A)
|
11.5 Percentage of Participants
|
3.1 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
24 Months: Moderate Acute (2A)
|
7.7 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
24 Months: Moderate Acute (2B)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With BANFF Grade by Severity Grades. BANFF Type (Grade) for Acute/Active Rejection
24 Months: Severe Acute
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: at 6, 12 and 24 MonthsPopulation: All Randomized, Transplanted and Treated Participants
Treatment Received for Biopsy Proven Acute Rejection (Banff Grade IA or Higher), or Humoral (Antibody Mediated) Rejection Treatment regimen: Categorical analysis of CSBPAR episodes by treatment received.
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Treatment Differences in Therapeutic Modalities
Corticosteroids (6 months)
|
7.7 Percentage of participants with CSBPARs
|
9.4 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
IVIG (12 months)
|
0 Percentage of participants with CSBPARs
|
3.1 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Rituximab (12 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Lymphocyte depleting agent (6 months)
|
0 Percentage of participants with CSBPARs
|
6.3 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Plasmapheresis (6 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
IVIG (6 months)
|
0 Percentage of participants with CSBPARs
|
3.1 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Rituximab (6 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Corticosteroids (12 months)
|
15.4 Percentage of participants with CSBPARs
|
12.5 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Lymphocyte depleting agent (12 months)
|
3.8 Percentage of participants with CSBPARs
|
6.3 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Plasmapheresis (12 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Corticosteroids (24 months)
|
19.2 Percentage of participants with CSBPARs
|
12.5 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Lymphocyte depleting agent (24 months)
|
3.8 Percentage of participants with CSBPARs
|
6.3 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Plasmapheresis (24 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
IVIG (24 months)
|
0 Percentage of participants with CSBPARs
|
3.1 Percentage of participants with CSBPARs
|
|
Treatment Differences in Therapeutic Modalities
Rituximab (24 months)
|
0 Percentage of participants with CSBPARs
|
0 Percentage of participants with CSBPARs
|
SECONDARY outcome
Timeframe: At 6, 12 and 24 monthsPopulation: All Treated Participants
Number of all participants who survive with a functioning graft at 6, 12 and 24 months post transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Number of Participants Who Survive With a Functioning Graft
At 6 Months
|
25 Participants
|
31 Participants
|
|
Number of Participants Who Survive With a Functioning Graft
At 12 Months
|
25 Participants
|
31 Participants
|
|
Number of Participants Who Survive With a Functioning Graft
At 24 Months
|
25 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: All Treated Participants
Number of participant deaths at 6, 12 and 24 months post transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Number of Participants Deaths Post Transplant
At 6 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants Deaths Post Transplant
At 12 Months
|
0 Participants
|
0 Participants
|
|
Number of Participants Deaths Post Transplant
At 24 Months
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 6, 12 and 24 monthsPopulation: ITT Population
Number of all participants who experience graft loss at 6, 12 and 24 months post transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Number of Participants Who Experience Graft Loss Post Transplant
At 6 Months
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experience Graft Loss Post Transplant
At 12 Months
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experience Graft Loss Post Transplant
At 24 Months
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 728 DaysPopulation: All Treated Participants
The Number of days to participant Graft Loss and death for any reason
Outcome measures
| Measure |
Treatment A
n=1 Participants
BELA + EVL
|
Treatment B
n=1 Participants
TAC + MMF
|
|---|---|---|
|
Time to Event: Graft Loss and Death
Graft Loss
|
107 Days
|
2 Days
|
SECONDARY outcome
Timeframe: Up 24 Months post-transplantPopulation: ITT Population
Absolute (mean and median) cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
At 6 Months
|
66.0 mL/min/1.73 m^2
Interval 55.8 to 76.2
|
63.9 mL/min/1.73 m^2
Interval 56.2 to 71.5
|
|
Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
At 12 Months
|
66.2 mL/min/1.73 m^2
Interval 56.9 to 75.4
|
62.0 mL/min/1.73 m^2
Interval 53.4 to 70.6
|
|
Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
At 24 Months
|
71.8 mL/min/1.73 m^2
Interval 62.5 to 81.0
|
68.7 mL/min/1.73 m^2
Interval 59.2 to 78.2
|
|
Absolute Calculated Glomerular Filtration Rate (cGFR): Mean
At 3 Months
|
69.2 mL/min/1.73 m^2
Interval 60.2 to 78.3
|
62.2 mL/min/1.73 m^2
Interval 55.3 to 69.1
|
SECONDARY outcome
Timeframe: Up 24 Months post-transplantPopulation: ITT Population
Median cGFR values at 3, 6, 12 and 24 months post-transplant, as determined from the 4-variable Modification of Diet in Renal Disease (MDRD) formula
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Median Calculated Glomerular Filtration Rate (cGFR)
At 3 Months
|
64.0 mL/min/1.73 m^2
Interval 52.0 to 80.0
|
62.0 mL/min/1.73 m^2
Interval 55.0 to 79.0
|
|
Median Calculated Glomerular Filtration Rate (cGFR)
At 6 Months
|
64.0 mL/min/1.73 m^2
Interval 56.0 to 79.0
|
67.0 mL/min/1.73 m^2
Interval 55.0 to 75.0
|
|
Median Calculated Glomerular Filtration Rate (cGFR)
At 12 Months
|
66.0 mL/min/1.73 m^2
Interval 58.0 to 77.0
|
62.5 mL/min/1.73 m^2
Interval 47.5 to 74.0
|
|
Median Calculated Glomerular Filtration Rate (cGFR)
At 24 Months
|
73.5 mL/min/1.73 m^2
Interval 59.5 to 84.5
|
68.0 mL/min/1.73 m^2
Interval 56.0 to 82.0
|
SECONDARY outcome
Timeframe: Up 24 Months post-transplantPopulation: ITT Population
The mean change from Month 3 cGFR at 3, 6, 12 and 24 months post-transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Mean Change From Month 3 in cGFR
At 3 Months
|
0 mL/min/1.73 m^2
Interval 0.0 to 0.0
|
0 mL/min/1.73 m^2
Interval 0.0 to 0.0
|
|
Mean Change From Month 3 in cGFR
At 6 Months
|
-3.2 mL/min/1.73 m^2
Interval -10.9 to 4.5
|
2.8 mL/min/1.73 m^2
Interval -0.2 to 5.8
|
|
Mean Change From Month 3 in cGFR
At 12 Months
|
-3.1 mL/min/1.73 m^2
Interval -12.6 to 6.5
|
1.4 mL/min/1.73 m^2
Interval -3.3 to 6.0
|
|
Mean Change From Month 3 in cGFR
At 24 Months
|
3.1 mL/min/1.73 m^2
Interval -4.2 to 10.4
|
6.3 mL/min/1.73 m^2
Interval -0.6 to 13.2
|
SECONDARY outcome
Timeframe: Up 24 Months post-transplantPopulation: ITT Population
Urine protein to creatinine ratio (UPr/Cr) at 3, 6, 12 and 24 months post-transplant.
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Urine Protein Creatinine Ratio (UPr/Cr)
At 3 Months
|
0.3146 mg Protein/mg Creatinine
Interval 0.1985 to 0.4307
|
0.1412 mg Protein/mg Creatinine
Interval 0.1097 to 0.1726
|
|
Urine Protein Creatinine Ratio (UPr/Cr)
At 6 Months
|
0.3896 mg Protein/mg Creatinine
Interval 0.2326 to 0.5466
|
0.1461 mg Protein/mg Creatinine
Interval 0.1203 to 0.172
|
|
Urine Protein Creatinine Ratio (UPr/Cr)
At 12 Months
|
0.2835 mg Protein/mg Creatinine
Interval 0.1648 to 0.4021
|
0.1849 mg Protein/mg Creatinine
Interval 0.1041 to 0.2658
|
|
Urine Protein Creatinine Ratio (UPr/Cr)
At 24 Months
|
0.3940 mg Protein/mg Creatinine
Interval 0.2199 to 0.568
|
0.1685 mg Protein/mg Creatinine
Interval 0.1174 to 0.2195
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: As Treated Population
Percentage of participants with, and titers of pre-existing (pre-transplant) DSA on Day 1 (pre-transplant, pre-dose), and at Months 12 and 24 posttransplant
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Baseline Class 1 DSA
|
10 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Baseline Class 2 DSA
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
12 Month Class 1 DSA
|
8.00 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
Baseline Both Class 1 and 2 DSA
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
12 Month Class 2 DSA
|
0 Percentage of Participants
|
3.03 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
12 Month Both Class 1 and 2 DSA
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
24 Month Class 1 DSA
|
8.00 Percentage of Participants
|
3.03 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
24 Month Class 2 DSA
|
0 Percentage of Participants
|
3.03 Percentage of Participants
|
|
Percentage of Participants With Donor Specific Anti-HLA Antibodies (DSA)
24 Month Both Class 1 and 2 DSA
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: As Treated Population
Characterization of any de novo DSA detected by IgM and IgG subclasses, and by the presence or absence of complement fixing properties.
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Baseline Class 1 DSA
|
10 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 24 Month Both Class 1 and 2 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Baseline Class 2 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
Baseline Both Class 1 and 2 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 12 Month Class 1 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 12 Month Class 2 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 12 Month Both Class 1 and 2 DSA
|
0 Percentage
|
0 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 24 Month Class 1 DSA
|
0 Percentage
|
3.45 Percentage
|
|
Percentage of Participants With De Novo Donor Specific Anti-HLA Antibodies (DSA)
De Novo 24 Month Class 2 DSA
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: Up to 24 months Post-TransplantPopulation: As Treated Population
Percentage of participants with AEs up to 24 months post-transplant
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
100.0 Percentage of participants with AEs
|
97.0 Percentage of participants with AEs
|
SECONDARY outcome
Timeframe: Up to 24 months Post-TransplantPopulation: As Treated Population
Percentage of participants with SAEs up to 24 months post-transplant
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
52.0 Percentage of participants with SAEs
|
60.6 Percentage of participants with SAEs
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: As Treated Population
Percentage of participants which have one of the following events of special interest: Serious Infections Post-Transplant Lymphoproliferative Disorder (PTLD) Progressive multifocal leukoencephalopathy (PML) Malignancies (Other than PTLD) including non-melanoma skin carcinomas (Malignancies) Tuberculosis Infections Central Nervous System (CNS) Infections Viral Infections Infusion Related reactions within 24 hours since belatacept infusion
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With Events of Special Interest (ESIs)
Serious Infections
|
16 Percentage of participants with ESIs
|
15.2 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
PTLD
|
4.0 Percentage of participants with ESIs
|
3.0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
Malignancies
|
4.0 Percentage of participants with ESIs
|
3.0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
PML
|
0 Percentage of participants with ESIs
|
0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
TB
|
0 Percentage of participants with ESIs
|
0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
CNS Infections
|
0 Percentage of participants with ESIs
|
0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
Viral Infections
|
0 Percentage of participants with ESIs
|
0 Percentage of participants with ESIs
|
|
Percentage of Participants With Events of Special Interest (ESIs)
Infusion Related Reactions
|
1 Percentage of participants with ESIs
|
0 Percentage of participants with ESIs
|
SECONDARY outcome
Timeframe: At 24 MonthsPopulation: As Treated Population
Percentage of participants with laboratory tests with marked laboratory abnormalities
Outcome measures
| Measure |
Treatment A
n=25 Participants
BELA + EVL
|
Treatment B
n=33 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Hemoglobin (Low)
|
12.0 Percentage of participants
|
6.1 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Leukocytes (low)
|
0 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Lymphocyte (Absolute) (low)
|
84.0 Percentage of participants
|
69.7 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Neutrophils (Absolute) (low)
|
0 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Aspartate Aminotransferase (High)
|
4.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Creatinine (High)
|
16.0 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Inorganic Phosphorus (low)
|
24.0 Percentage of participants
|
12.1 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Potassium (high)
|
4.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Sodium (low)
|
4.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Albumin (low)
|
0 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Glucose (high)
|
8.0 Percentage of participants
|
12.1 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Triglycerides (high)
|
12.0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Particpants With Laboratory Test Abnormalities (LTAs)
Uric Acid (high)
|
8.0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: ITT Population
Mean fasting blood glucose levels, and mean changes from baseline values at Months 6, 12 and 24 months post- transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Mean and Mean Change From Baseline in Blood Glucose
Mean Value at 6 months
|
107.2 mg/dL
Interval 86.6 to 127.8
|
107.2 mg/dL
Interval 93.8 to 120.7
|
|
Mean and Mean Change From Baseline in Blood Glucose
Change from baseline at 6 months
|
4.9 mg/dL
Interval -5.8 to 15.7
|
4.8 mg/dL
Interval -17.6 to 27.2
|
|
Mean and Mean Change From Baseline in Blood Glucose
Mean Value at 12 months
|
101.1 mg/dL
Interval 85.3 to 117.0
|
127.5 mg/dL
Interval 99.2 to 155.8
|
|
Mean and Mean Change From Baseline in Blood Glucose
Change from baseline at 12 months
|
-1.3 mg/dL
Interval -24.7 to 22.1
|
20.6 mg/dL
Interval 0.4 to 40.8
|
|
Mean and Mean Change From Baseline in Blood Glucose
Mean Value at 24 months
|
127.5 mg/dL
Interval 93.7 to 161.4
|
111.8 mg/dL
Interval 87.1 to 136.5
|
|
Mean and Mean Change From Baseline in Blood Glucose
Change from baseline at 24 months
|
22.3 mg/dL
Interval -15.7 to 60.3
|
15.0 mg/dL
Interval -3.2 to 33.2
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: ITT Population
Mean whole blood HbA1C concentrations, and mean changes from baseline values at Months 6, 12 and 24 months post-transplant.
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Mean Value at 6 months
|
6.11 mg/dL
Interval 5.47 to 6.75
|
6.13 mg/dL
Interval 5.44 to 6.82
|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Change from baseline at 6 months
|
0.34 mg/dL
Interval 0.06 to 0.62
|
0.48 mg/dL
Interval 0.04 to 0.91
|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Mean Value at 12 months
|
6.18 mg/dL
Interval 5.42 to 6.93
|
6.21 mg/dL
Interval 5.5 to 6.92
|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Change from baseline at 12 months
|
0.47 mg/dL
Interval 0.0 to 0.95
|
0.32 mg/dL
Interval -0.17 to 0.81
|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Mean Value at 24 months
|
6.24 mg/dL
Interval 5.27 to 7.2
|
6.29 mg/dL
Interval 5.38 to 7.2
|
|
Mean and Mean Change From Baseline in Whole Blood HbA1c
Change from baseline at 24 months
|
0.66 mg/dL
Interval -0.05 to 1.37
|
0.41 mg/dL
Interval -0.13 to 0.95
|
SECONDARY outcome
Timeframe: up to 24 monthsPopulation: ITT Population
Percentage of participants with New Onset Diabetes After Transplantation (NODAT) at 6, 12, and 24 months post-transplant.
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Percentage of Participants With New Onset Diabetes After Transplant
Up to 6 Months
|
11.5 Percentage of participants
Interval 2.4 to 30.2
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
|
Percentage of Participants With New Onset Diabetes After Transplant
Up to 12 Months
|
11.5 Percentage of participants
Interval 2.4 to 30.2
|
6.3 Percentage of participants
Interval 0.8 to 20.8
|
|
Percentage of Participants With New Onset Diabetes After Transplant
Up to 24 Months
|
15.4 Percentage of participants
Interval 4.4 to 34.9
|
12.5 Percentage of participants
Interval 3.5 to 29.0
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Absolute Values of Blood Pressure: Mean
Diastolic Month 24
|
78.1 mmHg
Interval 74.2 to 81.9
|
78.5 mmHg
Interval 74.3 to 82.8
|
|
Absolute Values of Blood Pressure: Mean
Systolic Month 24
|
130.9 mmHg
Interval 125.2 to 136.5
|
131.7 mmHg
Interval 125.2 to 138.2
|
|
Absolute Values of Blood Pressure: Mean
Diastolic Month 3
|
78.7 mmHg
Interval 74.2 to 83.2
|
77.7 mmHg
Interval 74.0 to 81.3
|
|
Absolute Values of Blood Pressure: Mean
Systolic Month 3
|
134.2 mmHg
Interval 126.9 to 141.6
|
131.0 mmHg
Interval 124.9 to 137.0
|
|
Absolute Values of Blood Pressure: Mean
Diastolic Month 6
|
77.4 mmHg
Interval 73.6 to 81.3
|
79.4 mmHg
Interval 76.0 to 82.9
|
|
Absolute Values of Blood Pressure: Mean
Systolic Month 6
|
128.1 mmHg
Interval 121.8 to 134.5
|
133.0 mmHg
Interval 127.2 to 138.8
|
|
Absolute Values of Blood Pressure: Mean
Diastolic Month 12
|
78.7 mmHg
Interval 74.6 to 82.9
|
80.1 mmHg
Interval 76.4 to 83.8
|
|
Absolute Values of Blood Pressure: Mean
Systolic Month 12
|
131.0 mmHg
Interval 125.6 to 136.4
|
131.0 mmHg
Interval 123.4 to 138.7
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Absolute (mean and median) values for SBP and DBP at 3, 6, 12 and 24 months posttransplant;
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Absolute Values of Blood Pressure: Median
Diastolic Month 3
|
78.5 mmHg
Interval 70.0 to 88.0
|
80.0 mmHg
Interval 70.0 to 84.0
|
|
Absolute Values of Blood Pressure: Median
Systolic Month 3
|
135.5 mmHg
Interval 127.0 to 144.0
|
131.0 mmHg
Interval 122.0 to 138.0
|
|
Absolute Values of Blood Pressure: Median
Diastolic Month 6
|
75.5 mmHg
Interval 70.5 to 83.0
|
80.0 mmHg
Interval 71.0 to 85.5
|
|
Absolute Values of Blood Pressure: Median
Systolic Month 6
|
127.0 mmHg
Interval 114.5 to 136.5
|
131.0 mmHg
Interval 124.0 to 142.5
|
|
Absolute Values of Blood Pressure: Median
Diastolic Month 12
|
77.0 mmHg
Interval 71.5 to 86.0
|
81.0 mmHg
Interval 72.0 to 88.0
|
|
Absolute Values of Blood Pressure: Median
Systolic Month 12
|
130.0 mmHg
Interval 119.0 to 142.0
|
126.0 mmHg
Interval 115.0 to 146.0
|
|
Absolute Values of Blood Pressure: Median
Diastolic Month 24
|
78.0 mmHg
Interval 71.0 to 86.0
|
79.0 mmHg
Interval 69.5 to 85.0
|
|
Absolute Values of Blood Pressure: Median
Systolic Month 24
|
130.0 mmHg
Interval 122.0 to 142.0
|
130.0 mmHg
Interval 121.5 to 139.0
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Mean changes from baseline values for SBP and DBP at 6, 12 and 24 months post-transplant
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Mean Changes From Baseline Values for Blood Pressure
Diastolic Month 6
|
1.0 mmHg
Interval -4.7 to 6.7
|
4.8 mmHg
Interval -1.2 to 10.8
|
|
Mean Changes From Baseline Values for Blood Pressure
Systolic Month 6
|
-4.0 mmHg
Interval -13.9 to 5.9
|
-0.7 mmHg
Interval -10.0 to 8.7
|
|
Mean Changes From Baseline Values for Blood Pressure
Diastolic Month 12
|
2.3 mmHg
Interval -4.0 to 8.6
|
5.4 mmHg
Interval -1.0 to 11.7
|
|
Mean Changes From Baseline Values for Blood Pressure
Systolic Month 12
|
-1.1 mmHg
Interval -9.6 to 7.4
|
-3.2 mmHg
Interval -14.7 to 8.3
|
|
Mean Changes From Baseline Values for Blood Pressure
Diastolic Month 24
|
0.9 mmHg
Interval -5.5 to 7.3
|
2.1 mmHg
Interval -3.9 to 8.1
|
|
Mean Changes From Baseline Values for Blood Pressure
Systolic Month 24
|
-2.3 mmHg
Interval -12.2 to 7.6
|
-4.2 mmHg
Interval -14.4 to 6.0
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Absolute Values of Fasting Lipid Values: Mean
HDL Month 12
|
49.4 mg/dL
Interval 44.0 to 54.8
|
49.6 mg/dL
Interval 42.5 to 56.6
|
|
Absolute Values of Fasting Lipid Values: Mean
LDL Month 24
|
97.9 mg/dL
Interval 81.6 to 114.2
|
91.5 mg/dL
Interval 75.4 to 107.6
|
|
Absolute Values of Fasting Lipid Values: Mean
TG Month 24
|
263.4 mg/dL
Interval 131.2 to 395.5
|
145.0 mg/dL
Interval 99.8 to 190.2
|
|
Absolute Values of Fasting Lipid Values: Mean
TC Month 3
|
181.2 mg/dL
Interval 157.8 to 204.7
|
174.4 mg/dL
Interval 154.8 to 194.1
|
|
Absolute Values of Fasting Lipid Values: Mean
TC Month 6
|
197.7 mg/dL
Interval 177.9 to 217.4
|
175 mg/dL
Interval 158.8 to 191.6
|
|
Absolute Values of Fasting Lipid Values: Mean
TC Month 12
|
189.0 mg/dL
Interval 171.7 to 206.3
|
169.9 mg/dL
Interval 153.8 to 186.0
|
|
Absolute Values of Fasting Lipid Values: Mean
TC Month 24
|
193.2 mg/dL
Interval 172.1 to 214.2
|
168.2 mg/dL
Interval 152.9 to 183.4
|
|
Absolute Values of Fasting Lipid Values: Mean
HDL Month 3
|
50.6 mg/dL
Interval 43.5 to 57.6
|
50.4 mg/dL
Interval 43.9 to 56.9
|
|
Absolute Values of Fasting Lipid Values: Mean
HDL Month 6
|
46.4 mg/dL
Interval 41.3 to 51.5
|
53.9 mg/dL
Interval 45.9 to 61.8
|
|
Absolute Values of Fasting Lipid Values: Mean
HDL Month 24
|
50.1 mg/dL
Interval 44.7 to 55.5
|
51.3 mg/dL
Interval 43.0 to 59.6
|
|
Absolute Values of Fasting Lipid Values: Mean
LDL Month 3
|
96.9 mg/dL
Interval 77.9 to 115.9
|
96.5 mg/dL
Interval 80.3 to 112.6
|
|
Absolute Values of Fasting Lipid Values: Mean
LDL Month 6
|
115.2 mg/dL
Interval 98.1 to 132.3
|
93.7 mg/dL
Interval 79.2 to 108.2
|
|
Absolute Values of Fasting Lipid Values: Mean
LDL Month 12
|
107.5 mg/dL
Interval 92.8 to 122.2
|
88.0 mg/dL
Interval 74.3 to 101.8
|
|
Absolute Values of Fasting Lipid Values: Mean
TG Month 3
|
171.6 mg/dL
Interval 118.1 to 225.0
|
137.8 mg/dL
Interval 106.6 to 168.9
|
|
Absolute Values of Fasting Lipid Values: Mean
TG Month 6
|
180.0 mg/dL
Interval 140.2 to 219.7
|
138.3 mg/dL
Interval 108.0 to 168.5
|
|
Absolute Values of Fasting Lipid Values: Mean
TG Month 12
|
162.4 mg/dL
Interval 132.2 to 192.6
|
161.3 mg/dL
Interval 126.4 to 196.1
|
SECONDARY outcome
Timeframe: Up to 24 MonthsPopulation: ITT Population
Absolute (mean and median) values at 3, 6, 12 and 24 months post-transplant for the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Absolute Values of Fasting Lipid Values: Median
TC Month 3
|
167.0 mg/dL
Interval 160.0 to 213.0
|
173.0 mg/dL
Interval 146.0 to 197.0
|
|
Absolute Values of Fasting Lipid Values: Median
TC Month 24
|
193.0 mg/dL
Interval 166.0 to 206.0
|
166.0 mg/dL
Interval 137.0 to 201.0
|
|
Absolute Values of Fasting Lipid Values: Median
HDL Month 3
|
45.0 mg/dL
Interval 39.0 to 62.0
|
49.0 mg/dL
Interval 38.0 to 63.0
|
|
Absolute Values of Fasting Lipid Values: Median
HDL Month 12
|
50.0 mg/dL
Interval 40.0 to 58.0
|
47.0 mg/dL
Interval 37.0 to 61.0
|
|
Absolute Values of Fasting Lipid Values: Median
TC Month 6
|
187.0 mg/dL
Interval 170.5 to 226.5
|
178.0 mg/dL
Interval 146.0 to 199.0
|
|
Absolute Values of Fasting Lipid Values: Median
TC Month 12
|
184.0 mg/dL
Interval 166.0 to 213.0
|
171.5 mg/dL
Interval 146.5 to 193.5
|
|
Absolute Values of Fasting Lipid Values: Median
HDL Month 6
|
45.5 mg/dL
Interval 39.0 to 51.0
|
49.0 mg/dL
Interval 37.0 to 68.0
|
|
Absolute Values of Fasting Lipid Values: Median
HDL Month 24
|
49.0 mg/dL
Interval 43.0 to 58.0
|
49.0 mg/dL
Interval 35.0 to 71.0
|
|
Absolute Values of Fasting Lipid Values: Median
LDL Month 3
|
89.0 mg/dL
Interval 74.0 to 127.0
|
95.0 mg/dL
Interval 75.0 to 116.0
|
|
Absolute Values of Fasting Lipid Values: Median
LDL Month 6
|
99.5 mg/dL
Interval 85.5 to 143.0
|
100.0 mg/dL
Interval 66.0 to 115.0
|
|
Absolute Values of Fasting Lipid Values: Median
LDL Month 12
|
104.0 mg/dL
Interval 85.0 to 128.0
|
91.5 mg/dL
Interval 65.0 to 109.0
|
|
Absolute Values of Fasting Lipid Values: Median
LDL Month 24
|
103.5 mg/dL
Interval 74.0 to 121.0
|
86.0 mg/dL
Interval 70.0 to 119.0
|
|
Absolute Values of Fasting Lipid Values: Median
TG Month 3
|
147.0 mg/dL
Interval 107.0 to 195.0
|
128.0 mg/dL
Interval 81.0 to 174.0
|
|
Absolute Values of Fasting Lipid Values: Median
TG Month 6
|
157.5 mg/dL
Interval 113.5 to 245.5
|
126.0 mg/dL
Interval 85.0 to 194.0
|
|
Absolute Values of Fasting Lipid Values: Median
TG Month 12
|
154.0 mg/dL
Interval 100.0 to 230.0
|
130.0 mg/dL
Interval 106.0 to 202.0
|
|
Absolute Values of Fasting Lipid Values: Median
TG Month 24
|
159.0 mg/dL
Interval 137.0 to 284.0
|
114.0 mg/dL
Interval 80.0 to 174.0
|
SECONDARY outcome
Timeframe: at months 12 and 24Population: ITT Population
Mean changes from baseline values in the following: Serum total cholesterol (TC) Serum high density lipoprotein (HDL) cholesterol Serum low density lipoprotein (LDL) cholesterol Serum triglycerides (TG)
Outcome measures
| Measure |
Treatment A
n=26 Participants
BELA + EVL
|
Treatment B
n=32 Participants
TAC + MMF
|
|---|---|---|
|
Mean Changes From Baseline Values of Lipid Values
TC Month 12
|
25.7 mg/dL
Interval 3.5 to 47.9
|
-2.8 mg/dL
Interval -41.5 to 35.8
|
|
Mean Changes From Baseline Values of Lipid Values
TC Month 24
|
26.6 mg/dL
Interval 4.0 to 49.1
|
10.0 mg/dL
Interval -9.9 to 29.9
|
|
Mean Changes From Baseline Values of Lipid Values
HDL Month 12
|
5.4 mg/dL
Interval -0.3 to 11.0
|
1.9 mg/dL
Interval -3.7 to 7.5
|
|
Mean Changes From Baseline Values of Lipid Values
HDL Month 24
|
6.2 mg/dL
Interval 0.7 to 11.6
|
4.8 mg/dL
Interval -2.2 to 11.9
|
|
Mean Changes From Baseline Values of Lipid Values
LDL Month 12
|
25.7 mg/dL
Interval 7.9 to 43.4
|
10.8 mg/dL
Interval -10.8 to 32.4
|
|
Mean Changes From Baseline Values of Lipid Values
LDL Month 24
|
17.4 mg/dL
Interval 0.0 to 34.7
|
15.7 mg/dL
Interval -4.4 to 35.7
|
|
Mean Changes From Baseline Values of Lipid Values
TG Month 12
|
3.3 mg/dL
Interval -26.0 to 32.5
|
-86.1 mg/dL
Interval -288.9 to 116.7
|
|
Mean Changes From Baseline Values of Lipid Values
TG Month 24
|
106.8 mg/dL
Interval -32.6 to 246.2
|
-13.6 mg/dL
Interval -73.8 to 46.5
|
Adverse Events
BELA+EVL
Serious events: 13 serious events
Other events: 25 other events
Deaths: 0 deaths
TAC+MMF
Serious events: 20 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BELA+EVL
n=25 participants at risk
BELA + EVL
|
TAC+MMF
n=33 participants at risk
TAC + MMF
|
|---|---|---|
|
Renal and urinary disorders
Renal tubular necrosis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Ureteral necrosis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Ascites
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Immune system disorders
Renal transplant failure
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Renal graft infection
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Septic shock
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Blood creatinine increased
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Weight decreased
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Central nervous system vasculitis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Cerebellar ataxia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Bladder stenosis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Nephropathy toxic
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Perinephric collection
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Vascular disorders
Dry gangrene
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Vascular disorders
Iliac artery occlusion
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
Other adverse events
| Measure |
BELA+EVL
n=25 participants at risk
BELA + EVL
|
TAC+MMF
n=33 participants at risk
TAC + MMF
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Leukopenia
|
32.0%
8/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
21.2%
7/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Cardiac disorders
Atrial fibrillation
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Cardiac disorders
Palpitations
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Cardiac disorders
Tachycardia
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
30.3%
10/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
30.3%
10/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Flatulence
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Mouth ulceration
|
40.0%
10/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
39.4%
13/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
21.2%
7/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
General disorders
Chest pain
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
General disorders
Fatigue
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
General disorders
Oedema peripheral
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
General disorders
Pyrexia
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
BK virus infection
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Body tinea
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Bronchitis
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Fungal infection
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Onychomycosis
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Graft complication
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Injury, poisoning and procedural complications
Wound
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Blood creatinine increased
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Donor specific antibody present
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Hepatic enzyme increased
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Investigations
White blood cell count decreased
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Fluid overload
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
33.3%
11/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
28.0%
7/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
24.2%
8/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
36.0%
9/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
24.2%
8/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.0%
6/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
21.2%
7/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Hypoaesthesia
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Nervous system disorders
Tremor
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
18.2%
6/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
3.0%
1/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Dysuria
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Haematuria
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
12.1%
4/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Proteinuria
|
16.0%
4/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Renal impairment
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
9.1%
3/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Renal and urinary disorders
Urinary retention
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.0%
3/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
1/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
15.2%
5/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Vascular disorders
Hypertension
|
24.0%
6/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
24.2%
8/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Vascular disorders
Hypotension
|
0.00%
0/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
6.1%
2/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
|
Vascular disorders
Orthostatic hypotension
|
8.0%
2/25 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
0.00%
0/33 • Up to 24 months after last treatment dose
Because 1 participant ith BPAR had been randomized to the BELA+EVL group, but had then mistakenly been treated with TAC+MMF beginning on Day 1 and continuing through the entire 2-year study period, analysis was also performed using the modified ITT (as-treated) population, in which the participant was analyzed as having received TAC+MMF.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60