Trial Outcomes & Findings for Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD) (NCT NCT00697112)
NCT ID: NCT00697112
Last Updated: 2014-01-22
Results Overview
The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
Baseline
Results posted on
2014-01-22
Participant Flow
Participant milestones
| Measure |
Sirolimus
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
Met the Inclusion Criteria
|
52
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Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Sirolimus
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Overall Study
Adverse Event
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Did not meet inclusion criteria
|
1
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Baseline Characteristics
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Baseline characteristics by cohort
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Age, Continuous
|
48.7 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intention-to-Treat (ITT) population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
The study employ a questionnaire which included different clinical criteria to determine the main medical reason for the introduction of sirolimus (Rapamune) therapy after renal transplant. The physician responsible selected the one that was considered the main reason for introduction of sirolimus (Rapamune) as base immunosuppressive therapy.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Delay graft function
|
3.85 percentage of participants
Interval 0.47 to 13.21
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Calcineurin inhibitor (CNI) nephrotoxicity
|
40.38 percentage of participants
Interval 27.01 to 54.9
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Chronic allograft nephropathy
|
25.00 percentage of participants
Interval 14.03 to 38.95
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Metabolic disorders
|
5.77 percentage of participants
Interval 1.21 to 15.95
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
To prevent chronic allograft nephropathy
|
5.77 percentage of participants
Interval 1.21 to 15.95
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Tumoral history
|
5.77 percentage of participants
Interval 1.21 to 15.95
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Virological status
|
5.77 percentage of participants
Interval 1.21 to 15.95
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Expanded criteria donor characteristics
|
3.85 percentage of participants
Interval 0.47 to 13.21
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
Diarrhea
|
1.92 percentage of participants
Interval 0.05 to 10.26
|
|
Percentage of Participants With Main Reason for the Use of Sirolimus (Rapamune) Therapy
To prevent CNI nephrotoxicity
|
1.92 percentage of participants
Interval 0.05 to 10.26
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SECONDARY outcome
Timeframe: Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
Graft survival was considered in participants who did not experience graft failure. Graft failure was determined by return to dialysis for a period of at least 12 weeks with no return of function, or graft loss whichever occurred sooner.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Probability of Graft Survival
|
1 probability of graft survival
Confidence interval was not calculated as none of the participants had graft failure.
|
SECONDARY outcome
Timeframe: Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria: Grade 1A: significant interstitial infiltration (greater than \[\>\] 25 percent \[%\] of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: significant interstitial infiltration (\>25% of parenchyma affected) and severe tubulitis (\>10 mononuclear cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis comprising \>25% of the luminal area and Grade 3: transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells. Probability of no acute rejection throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Probability of no Acute Rejection
|
0.960 probability of no acute rejection
Interval 0.908 to 1.0
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SECONDARY outcome
Timeframe: Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
Participant's survival defined as participant living with or without a functioning graft. Probability of participant survival throughout the sirolimus (Rapamune) therapy was estimated using Kaplan-Meier method.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Probability of Participant Survival
|
0.979 probability of participant survival
Interval 0.938 to 1.0
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SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.
Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).
Outcome measures
| Measure |
Sirolimus
n=47 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Average Dose of Immunosuppressive Drugs Administered
Baseline: CsA (C0) (n=3)
|
200.00 milligram per day
Standard Deviation 50.00
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 52 or 53: Sirolimus (n=36)
|
2.05 milligram per day
Standard Deviation 0.89
|
|
Average Dose of Immunosuppressive Drugs Administered
Baseline: CsA (C2) (n=3)
|
306.67 milligram per day
Standard Deviation 83.27
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|
Average Dose of Immunosuppressive Drugs Administered
Baseline: Tacrolimus (n=40)
|
5.74 milligram per day
Standard Deviation 2.73
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|
Average Dose of Immunosuppressive Drugs Administered
Week 1 or 2: Tacrolimus (n=12)
|
4.79 milligram per day
Standard Deviation 2.28
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 1 or 2: Sirolimus (n=44)
|
2.43 milligram per day
Standard Deviation 0.84
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|
Average Dose of Immunosuppressive Drugs Administered
Week 4 or 5: CsA (C0) (n=1)
|
150.00 milligram per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 4 or 5: Tacrolimus (n=6)
|
3.67 milligram per day
Standard Deviation 2.93
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 4 or 5: Sirolimus (n=42)
|
2.52 milligram per day
Standard Deviation 0.80
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 12 or 13: Tacrolimus (n=4)
|
4.00 milligram per day
Standard Deviation 2.55
|
|
Average Dose of Immunosuppressive Drugs Administered
Week 12 or 13: Sirolimus (n=47)
|
2.45 milligram per day
Standard Deviation 0.94
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|
Average Dose of Immunosuppressive Drugs Administered
Week 24 or 25: Tacrolimus (n=2)
|
4.21 milligram per day
Standard Deviation 3.95
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|
Average Dose of Immunosuppressive Drugs Administered
Week 24 or 25: Sirolimus (n=46)
|
2.35 milligram per day
Standard Deviation 0.99
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|
Average Dose of Immunosuppressive Drugs Administered
Week 52 or 53: CsA (C0) (n=1)
|
100.00 milligram per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
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|
Average Dose of Immunosuppressive Drugs Administered
Week 52 or 53: Tacrolimus (n=1)
|
3.00 milligram per day
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: ITT population. N(number of participants analyzed)=participants evaluable for this measure. n=participants evaluable at given time point for specified immunosuppressive. Results not reported for CsA C0 at Week 1/2, 12/13, 24/25; CsA C2 at Week 1/2, 4/5, 12/13, 24/25, 52/53; sirolimus at baseline as no participants evaluable at those time points.
Immunosuppressive drugs administered included cyclosporin A (CsA) administration based on monitoring of plasma trough levels (C0), CsA administration based on monitoring of plasma levels 2-hours after CsA dose (C2), tacrolimus, and sirolimus (Rapamune).
Outcome measures
| Measure |
Sirolimus
n=47 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Average Blood Level of Immunosuppressive Drugs Administered
Baseline: CsA (C0) (n=3)
|
144.00 nanogram per milliliter (ng/mL)
Standard Deviation 36.66
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|
Average Blood Level of Immunosuppressive Drugs Administered
Baseline: CsA (C2) (n=3)
|
580.67 nanogram per milliliter (ng/mL)
Standard Deviation 251.64
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|
Average Blood Level of Immunosuppressive Drugs Administered
Baseline: Tacrolimus (n=40)
|
7.82 nanogram per milliliter (ng/mL)
Standard Deviation 2.14
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 4 or 5: CsA (C0) (n=1)
|
136.00 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
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|
Average Blood Level of Immunosuppressive Drugs Administered
Week 4 or 5: Tacrolimus (n=6)
|
7.00 nanogram per milliliter (ng/mL)
Standard Deviation 5.60
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|
Average Blood Level of Immunosuppressive Drugs Administered
Week 1 or 2: Tacrolimus (n=12)
|
8.12 nanogram per milliliter (ng/mL)
Standard Deviation 3.14
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|
Average Blood Level of Immunosuppressive Drugs Administered
Week 1 or 2: Sirolimus (n=44)
|
8.55 nanogram per milliliter (ng/mL)
Standard Deviation 3.83
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 4 or 5: Sirolimus (n=42)
|
7.81 nanogram per milliliter (ng/mL)
Standard Deviation 3.33
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|
Average Blood Level of Immunosuppressive Drugs Administered
Week 12 or 13: Tacrolimus (n=4)
|
5.42 nanogram per milliliter (ng/mL)
Standard Deviation 3.86
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 12 or 13: Sirolimus (n=47)
|
7.39 nanogram per milliliter (ng/mL)
Standard Deviation 2.25
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|
Average Blood Level of Immunosuppressive Drugs Administered
Week 24 or 25: Tacrolimus (n=2)
|
4.15 nanogram per milliliter (ng/mL)
Standard Deviation 1.91
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 24 or 25: Sirolimus (n=46)
|
7.75 nanogram per milliliter (ng/mL)
Standard Deviation 2.68
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 52 or 53: CsA (C0) (n=1)
|
86.00 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 52 or 53: Tacrolimus (n=1)
|
2.40 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation was not estimable since only 1 participant was evaluable.
|
|
Average Blood Level of Immunosuppressive Drugs Administered
Week 52 or 53: Sirolimus (n=36)
|
7.44 nanogram per milliliter (ng/mL)
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Creatinine clearance (CCr) is a measure of glomerular filtration rate (GMFR), an index of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliter per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Outcome measures
| Measure |
Sirolimus
n=51 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Average Creatinine Clearance
Week 4 or 5 (n=47)
|
51.51 milliliter per minute (mL/min)
Standard Deviation 21.45
|
|
Average Creatinine Clearance
Week 12 or 13 (n=48)
|
50.95 milliliter per minute (mL/min)
Standard Deviation 18.91
|
|
Average Creatinine Clearance
Week 24 or 25 (n=46)
|
49.52 milliliter per minute (mL/min)
Standard Deviation 19.77
|
|
Average Creatinine Clearance
Week 52 or 53 (n=38)
|
53.24 milliliter per minute (mL/min)
Standard Deviation 22.60
|
|
Average Creatinine Clearance
Baseline (n=51)
|
45.40 milliliter per minute (mL/min)
Standard Deviation 19.00
|
|
Average Creatinine Clearance
Week 1 or 2 (n=49)
|
50.56 milliliter per minute (mL/min)
Standard Deviation 18.02
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Proteinuria defined as the presence of an excess of serum proteins in the urine. Normal value of proteinuria is below 0.15 grams per 24 hours (g/24 hr).
Outcome measures
| Measure |
Sirolimus
n=29 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
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Average Proteinuria
Baseline (n=29)
|
0.17 g/24 hr
Standard Deviation 0.20
|
|
Average Proteinuria
Week 1 or 2 (n=24)
|
0.19 g/24 hr
Standard Deviation 0.16
|
|
Average Proteinuria
Week 4 or 5 (n=24)
|
0.37 g/24 hr
Standard Deviation 0.60
|
|
Average Proteinuria
Week 12 or 13 (n=25)
|
0.48 g/24 hr
Standard Deviation 0.89
|
|
Average Proteinuria
Week 24 or 25 (n=23)
|
0.60 g/24 hr
Standard Deviation 1.16
|
|
Average Proteinuria
Week 52 or 53 (n=18)
|
0.45 g/24 hr
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
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|---|---|
|
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy
|
15.38 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Inefficacy
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: ITT population included all participants who were treated with Rapamune for at least 4 or 5 weeks.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants who discontinued sirolimus (Rapamune) therapy prematurely due to AE were obliged to discontinue sirolimus (Rapamune) therapy permanently, are reported.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants Who Prematurely Discontinued the Sirolimus (Rapamune) Therapy Due to Adverse Events
|
15.38 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
BMI was calculated as weight divided by height squared and measured as kilogram per square meter (kg/m\^2).
Outcome measures
| Measure |
Sirolimus
n=24 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Body Mass Index
Baseline (n=24)
|
24.48 kg/m^2
Standard Deviation 3.65
|
|
Body Mass Index
Week 1 or 2 (n=18)
|
23.74 kg/m^2
Standard Deviation 3.69
|
|
Body Mass Index
Week 4 or 5 (n=24)
|
24.94 kg/m^2
Standard Deviation 4.26
|
|
Body Mass Index
Week 12 or 13 (n=17)
|
24.70 kg/m^2
Standard Deviation 3.99
|
|
Body Mass Index
Week 24 or 25 (n=17)
|
25.01 kg/m^2
Standard Deviation 3.76
|
|
Body Mass Index
Week 52 or 53 (n=13)
|
24.06 kg/m^2
Standard Deviation 3.16
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: Safety population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points. Results for hypothermia not reported as none of the participants was found hypothermic.
Body temperature was measured in degree Celsius. Each participants were classified into three different categories based on their body temperature: body temperature less than 35 degree Celsius = hypothermia, body temperature between 35 to 37.5 degree Celsius = feverless, and body temperature greater than 37.5 degree Celsius = fever.
Outcome measures
| Measure |
Sirolimus
n=26 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Number of Participants With Body Temperature
Baseline: Feverless (n=21)
|
21 participants
|
|
Number of Participants With Body Temperature
Week 1 or 2: Feverless (n=26)
|
26 participants
|
|
Number of Participants With Body Temperature
Week 4 or 5: Feverless (n=25)
|
25 participants
|
|
Number of Participants With Body Temperature
Week 12 or 13: Feverless (n=17)
|
16 participants
|
|
Number of Participants With Body Temperature
Week 12 or 13: Fever (n=17)
|
1 participants
|
|
Number of Participants With Body Temperature
Week 24 or 25: Feverless (n=17)
|
17 participants
|
|
Number of Participants With Body Temperature
Week 52 or 53: Feverless (n=14)
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Systolic and diastolic blood pressure (BP) was measured after the participant had rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg).
Outcome measures
| Measure |
Sirolimus
n=48 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Blood Pressure
Baseline: Diastolic BP (n=48)
|
77.2 mmHg
Standard Deviation 11.7
|
|
Blood Pressure
Week 1 or 2: Systolic BP (n=48)
|
125.7 mmHg
Standard Deviation 13.4
|
|
Blood Pressure
Week 1 or 2: Diastolic BP (n=48)
|
77.6 mmHg
Standard Deviation 9.3
|
|
Blood Pressure
Week 4 or 5: Systolic BP (n=45)
|
127.4 mmHg
Standard Deviation 19.8
|
|
Blood Pressure
Baseline: Systolic BP (n=48)
|
127.8 mmHg
Standard Deviation 15.8
|
|
Blood Pressure
Week 4 or 5: Diastolic BP (n=45)
|
75.6 mmHg
Standard Deviation 9.6
|
|
Blood Pressure
Week 12 or 13: Systolic BP (n=47)
|
131.4 mmHg
Standard Deviation 17.1
|
|
Blood Pressure
Week 12 or 13: Diastolic BP (n=47)
|
79.3 mmHg
Standard Deviation 9.8
|
|
Blood Pressure
Week 24 or 25: Systolic BP (n=40)
|
128.9 mmHg
Standard Deviation 18.9
|
|
Blood Pressure
Week 24 or 25: Diastolic BP (n=40)
|
77.0 mmHg
Standard Deviation 9.9
|
|
Blood Pressure
Week 52 or 53: Systolic BP (n=37)
|
127.5 mmHg
Standard Deviation 15.7
|
|
Blood Pressure
Week 52 or 53: Diastolic BP (n=37)
|
77.8 mmHg
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Outcome measures
| Measure |
Sirolimus
n=31 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Pulse Rate
Baseline (n=26)
|
74.0 beats per minute
Standard Deviation 7.9
|
|
Pulse Rate
Week 1 or 2 (n=27)
|
77.4 beats per minute
Standard Deviation 7.2
|
|
Pulse Rate
Week 4 or 5 (n=31)
|
77.2 beats per minute
Standard Deviation 9.0
|
|
Pulse Rate
Week 12 or 13 (n=22)
|
73.2 beats per minute
Standard Deviation 9.7
|
|
Pulse Rate
Week 24 or 25 (n=22)
|
75.3 beats per minute
Standard Deviation 10.1
|
|
Pulse Rate
Week 52 or 53 (n=22)
|
76.2 beats per minute
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline, Week 1 or 2, 4 or 5, 12 or 13, 24 or 25, 52 or 53Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluable for this measure at given time points.
Outcome measures
| Measure |
Sirolimus
n=46 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Body Weight
Baseline (n=46)
|
70.78 kilogram
Standard Deviation 14.50
|
|
Body Weight
Week 1 or 2 (n=46)
|
71.17 kilogram
Standard Deviation 13.76
|
|
Body Weight
Week 4 or 5 (n=45)
|
70.87 kilogram
Standard Deviation 14.25
|
|
Body Weight
Week 12 or 13 (n=43)
|
72.85 kilogram
Standard Deviation 13.11
|
|
Body Weight
Week 24 or 25 (n=37)
|
72.18 kilogram
Standard Deviation 13.48
|
|
Body Weight
Week 52 or 53 (n=34)
|
70.96 kilogram
Standard Deviation 13.77
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
Physical abnormalities included all the abnormalities related to general disorders and administration site conditions, gastrointestinal disorders, skin and subcutaneous tissue disorders, vascular disorders, investigations, infections and infestations, eye disorders, respiratory, thoracic and mediastinal disorders, nervous system disorders, musculoskeletal and connective tissue disorders, injury, poisoning and procedural complications, surgical and medical procedures, psychiatric disorders, neoplasms benign, malignant and unspecified (incl cysts and polyps), ear and labyrinth disorders, and congenital, familial and genetic disorders.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants With Physical Abnormalities
|
69.23 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants With Adverse Events
|
88.46 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants With Serious Adverse Events
|
40.38 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
Standard 12-lead ECG was performed. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization), QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval) and heart rate (time interval between consecutive heart beats \[RR interval\]).
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants With Clinically-Significant Electrocardiogram Abnormalities
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: Safety population included all participants who had received at least 1 dose of Rapamune and were subsequently interrogated.
Radiological examination was performed to evaluate presence or signs of infections or pneumonitis.
Outcome measures
| Measure |
Sirolimus
n=52 Participants
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Percentage of Participants With Clinically-Significant Radiological Abnormalities
|
0 percentage of participants
|
Adverse Events
Sirolimus
Serious events: 21 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sirolimus
n=52 participants at risk
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Infections and infestations
Escherichia urinary tract infection
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Klebsiella infection
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia escherichia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sepsis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Zygomycosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Generalised oedema
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Spinal pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Neurological decompensation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Renal lymphocele
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Transplant rejection
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Leg amputation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine increased
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Sirolimus
n=52 participants at risk
Participants who had kidney transplant from expanded criteria donors (ECD) and received sirolimus (Rapamune) as base therapy in immunosuppressive regimen according to the standard clinical practice as determined by the physician, were followed up for 1 year. The term ECD refers to kidneys from deceased donors who were either 60 years and older or aged 50 to 59 years with 2 of 3 conditions (serum creatinine level greater than \[\>\] 1.5 milligram per deciliter \[mg/dL\], cerebrovascular accident as cause of death or history of hypertension).
|
|---|---|
|
Infections and infestations
Escherichia urinary tract infection
|
11.5%
6/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candidiasis
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Onychomycosis
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory tract infection
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Furuncle
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Genital herpes
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral herpes
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media acute
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonsillitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pseudomonas infection
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth abscess
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
25.0%
13/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
13.5%
7/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Lymphocele
|
7.7%
4/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Haematoma
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Varicose ulceration
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
23.1%
12/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Faecaloma
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gingivitis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.6%
5/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
15.4%
8/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Hydronephrosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
5.8%
3/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatine increased
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Blister
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Aphasia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Polyneuropathy
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Visual field defect NOS
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctival irritation
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
2/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulvovaginal human papilloma virus infection
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Breast calcifications
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Haematospermia
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Panic attack
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Transplant rejection
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Deafness
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Epidermal naevus
|
1.9%
1/52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER