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The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| belatacept, mycophenolate mofetil (MMF) | Experimental | thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF 1g twice daily(bis in die, BID) |
|
| belatacept, sirolimus | Experimental | thymoglobulin 1.5mg/kg for 4 days;IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until 12 months;sirolimus 5 mg/day on Day 1 (day of transplant)and continued through Day 2, dosing to be adjusted to keep pre-dose C0 levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until 12 months. |
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| tacrolimus, MMF | Other | (IMPs as comparator regimen)thymoglobulin 1.5mg/kg for 4 days; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug | Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population | AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells. | Day 1 to Month 6 post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population | AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ucsf | San Francisco | California | 94143 | United States | ||
| Denver Nephrology, Pc |
Epstein-Barr virus positive recipients of renal allograft from living or deceased donor. Excluded if panel reactive antibodies greater than, equal to (>=) 50 % or prior graft loss due to acute rejection. 93 participants randomized; 89 transplanted/treated: (1) fever on the day of surgery, (1) problem with allograft, and (2) withdrawal of consent.
First 6 months (July 2007 to October 2008) assessed acute rejection of the renal transplant up to that time. All outcome measures were also assessed at 12 months post transplantation. Participants who wished to continue into the long term extension (LTE) signed a new consent form and were evaluated at 24, 36, and 48 Months post transplantation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Belatacept, Mycophenolate Mofetil (MMF) | Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Short Term Period |
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| Belatacept | Drug | Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial |
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| Sirolimus | Drug | Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter |
|
| Tacrolimus | Drug | The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial |
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| Mycophenolate Mofetil (MMF) | Drug | Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial |
|
| Day 1 to Month 12 post transplantation |
| Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population | Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted. | Day 1 to Month 6 and Month 12 post transplantation |
| Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population | Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss. | Day 1 up to Month 6 |
| Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population | Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss. | Day 1 up to Month 12 |
| Number of Participants With Delayed Graft Function - Intent to Treat Population | Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted | From Day 1 up to and including Day 8 post transplantation |
| Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population | Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation. Intent to treat population included all participants randomized and transplanted. | Baseline to Month 12 |
| Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population | Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted. | Baseline and Month 12 |
| Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population | Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted. | Baseline and 12 months post transplantation |
| Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population | Participants using > = 1 antihyperlipidemic medication at Month 12. | Month 12 |
| Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population | Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted. | Baseline to Month 12 |
| Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population | Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted. | Months 3, 6 and 12 post transplantation |
| Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population | Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants. | Day 1 through Month 12 |
| Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population | Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants. | Day 1 to Month 12 post transplantation |
| Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension | AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants. | End of Month 12 to end of Month 48 Post Transplantation |
| Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted. | End of Month 12 to end of Long Term Extension (Year 4) |
| Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension | GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted. | Months 24, 36 and 48 post transplantation |
| Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. | End of Month 12 to end of Long Term Extension (Year 4) |
| Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. | Months 24, 36, 48 |
| Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion | Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock. | End of Month 12 to end of Study (Month 48) |
| Denver |
| Colorado |
| 80218 |
| United States |
| University Of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| Medical College Of Georgia | Augusta | Georgia | 30912 | United States |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | United States |
| Henry Ford Hospital | Detriot | Michigan | 48202 | United States |
| Albany Medical College | Albany | New York | 12208 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| University Of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Local Institution | Bologna | Bologna | 40138 | Italy |
| Local Institution | Brescia | 25123 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Roma | 00168 | Italy |
| Local Institution | Barcelona | 08907 | Spain |
| Local Institution | Seville | 41013 | Spain |
| FG001 | Belatacept, Sirolimus | Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg. |
| FG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg. |
| COMPLETED |
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| NOT COMPLETED |
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| Long Term Extension (LTE) |
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All participants who received transplant and were treated with drug were analyzed up to Month 12 post transplant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Belatacept, Mycophenolate Mofetil (MMF) | Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus. |
| BG001 | Belatacept, Sirolimus | Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF. |
| BG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| Primary | Number of Participants With Acute Rejection (AR) of Transplant up to 6 Months Post Transplantation - Intent to Treat (ITT) Population | AR is clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) greater than or equal to 25% from baseline plus one or more of the following: unexplained decreased urine output; fever, graft tenderness; SCr that remained elevated 14 days post-transplantation and clinical suspicion of AR; other reason and participant treated for episode. Day 1=transplantation. Banff 97 working classification of kidney transplant pathology: Type I=tubulointerstitial AR without arteritis (IA: interstitial infiltration with >25% of parenchyma affected and moderate tubulitis with >4 mononuclear cells/tubular cross section; IB: >10 mononuclear cells; Type II vascular AR with (IA) intimal arteritis (IIA=mild - moderate; IIB=severe; Type III=severe rejection with transmural arterial changes, necrosis of smooth muscle cells. | Participants with more than one episode of AR were counted once only and the episode with the worst grade was used. For 95% Confidence Interval (CI) within each group, normal approximation was used if N greater than, or equal to (>=) 5. Otherwise, exact method was used. ITT population defined as all randomized and transplanted participants. | Posted | Number | participants | Day 1 to Month 6 post-transplantation |
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| Secondary | Number of Participants With Acute Rejection of Transplant up to Month 12 Post Transplantation - Intent to Treat Population | AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants. | For 95% CI within each group, normal approximation was used if N greater than, equal to 5. Otherwise, exact method was used. | Posted | Number | participants | Day 1 to Month 12 post transplantation |
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| Secondary | Number of Participants With Graft Loss or Death up to Month 6 and Month 12 Post Transplantation - Intent to Treat Population | Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted. | Participants surviving with a functioning graft were 30, 24, 30 in belatacept/MMF, belatacept/sirolimus, tacrolimus/MMF arms, respectively. Participant who died had functioning graft at time of death. | Posted | Number | participants | Day 1 to Month 6 and Month 12 post transplantation |
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| Secondary | Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 6 - Intent to Treat Population | Participants with graft loss or death prior to Month 6 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss. | Intent to treat population included all randomized and transplanted participants. | Posted | Number | participants | Day 1 up to Month 6 |
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| Secondary | Number of Participants With Composite of Death, Graft Loss and Acute Rejection up to Month 12 - Intent to Treat Population | Subjects with graft loss or death prior to Month 12 were considered having an event of AR, therefore, the incidence of AR was reported as a composite of AR, death, and graft loss. | Posted | Number | participants | Day 1 up to Month 12 |
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| Secondary | Number of Participants With Delayed Graft Function - Intent to Treat Population | Delayed graft function (DGF) is defined as participant requiring dialysis within the first week (Day 1-8) post transplantation. Participants losing their graft less than 48 hours post transplant and receiving chronic dialysis were not considered as having DGF. Day 1 was day of transplantation. Intent to treat population defined as all participants randomized and transplanted | Posted | Number | participants | From Day 1 up to and including Day 8 post transplantation |
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| Secondary | Number of Participants With New Onset Diabetes Mellitus From Baseline to Month 12 Post Transplantation - Intent to Treat Population | Baseline defined as day before transplantation. A participant who did not have diabetes prior to randomization and received an antidiabetic medication for a duration of at least 30 days or a participant who meets the following criteria and did not have diabetes prior to randomization: Symptoms of diabetes plus casual plasma glucose (PG) concentration ≥ 200 mg/dL (11.1 mmol/L); or fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L); or 2-hour PG ≥ 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test and a confirmatory laboratory test based on measurements of venous PG must have been done on another day in the absence of unequivocal hyperglycemia accompanied by acute metabolic decompensation. Intent to treat population included all participants randomized and transplanted. | Posted | Number | participants | Baseline to Month 12 |
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| Secondary | Number of Participants Who Used Anti-hypertension Medications at Baseline and at 12 Months Post Transplantation - Intent to Treat Population | Baseline was defined as day prior to transplantation. Number of anti-hypertension medications taken were categorized from 1 to 6 and greater than (>)6. Intent to treat population included all participants randomized and transplanted. | ITT population, 33, 26, 30 for each arm, respectively, was used for each time point (baseline and Month 12). At baseline, 2 participants in each arm were not using at least one medication. 8, 6, and 10 participants in each arm respectively, were not using at least one medication at Month 12. | Posted | Number | participants | Baseline and Month 12 |
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| Secondary | Mean Systolic, Diastolic and Arterial Blood Pressure at Baseline and Month 12 - Intent to Treat Population | Systolic, diastolic and mean arterial blood pressures were measured in millimeters of mercury (mm Hg). Baseline was defined as value obtained before transplantation. Intent to treat population included all participants randomized and transplanted. | Number analyzed at baseline presented above. Number analyzed at Month 12: 28, 22, 29 in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF treatment arms,respectively. Measurements obtained immediately after drug infusion were excluded from analysis. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 12 months post transplantation |
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| Secondary | Number of Participants Using Antihyperlipidemic Medications at Month 12 - Intent to Treat Population | Participants using > = 1 antihyperlipidemic medication at Month 12. | Analysis based on all participants who were followed up at least 364 days. | Posted | Number | participants | Month 12 |
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| Secondary | Mean Change From Baseline (BL) to Month 12 Post Transplantation in Lipid Values - Intent to Treat Population | Baseline (BL) was value obtained day prior to transplantation. Lipid values measured in milligrams/deciliter (mg/dL) included: high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), non-HDL cholesterol (non-HDL-C), total cholesterol (TC), triglycerides. Intent to treat population included all participants randomized and transplanted. | 33, 26, 30 participants were included in the ITT population. Number of participants analyzed for HDL-C = 26, 22, 26; non-HDL-C = 26, 22, 26; LDL-C = 20, 14, 21; TC = 26, 22, 26; triglycerides = 20, 14, 21, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline to Month 12 |
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| Secondary | Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Month 3, Month 6 and Month 12 Post Transplantation - Intent to Treat Population | Blood urea nitrogen (BUN) in mg/dL; Albumin (Alb) in g/dL;Serum creatinine (SCr) in mg/dL; Age in years. Glomerular filtration rate (GFR) was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Intent to Treat (ITT) population is defined as all participants randomized and transplanted. | Month 12 n presented above. Calculated GFR, values >180 mL/min/1.73 m2 (beyond upper limit of biologic plausibility)were truncated at 180 mL/min/1.73 m^2. Based on median (SD) GFR of 83 (50). | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Months 3, 6 and 12 post transplantation |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Corticosteroid-free Participants at 6 and 12 Months Post Transplantation - Intent to Treat Population | Participants were said to be corticosteroid-free at Month 6 if they were not receiving corticosteroids for greater than (>) 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Intent to treat population included all randomized and transplanted participants. | For 95% CI within each group, normal approximation was used if N greater than, equal to (>=)5. Otherwise, exact method was used. Numbers of participants analyzed at Month 6 in each arm were 33, 26, 30 and numbers of participants analyzed at Month 12 were 32, 26, 30, in belatacept/MMF, belatacept/sirolimus, and tacrolimus/MMF arms, respectively. | Posted | Number | participants | Day 1 through Month 12 |
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| Secondary | Number of Participants Who Were Corticosteroid-free at Months 6 and 12 and Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 6 and 12 Post Transplantation - Intent to Treat Population | Participants were said to be CNI-free at Month 6 or 12 if they were not receiving a CNI during Day 141 to Day 196, or Day 337 to Day 392. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. Participants were corticosteroid-free (CS-free) at Month 6 if they were not receiving corticosteroids for > 7 consecutive days during Days 141 through Days 196, and at Month 12 if not receiving corticosteroids for > 7 days during Days 337 through 392. Day 1 was day of transplantation. Intent to treat population included all randomized and transplanted participants. | Analysis on both CNI-free and CS-free participants based on all followed up at least 151 days for Month 6 or 347 days for Month 12. One participant in the tacrolimus arm was counted as CNI-free since he discontinued tacrolimus on Day 2 of transplant and no data were available regarding immunosuppressive therapy after discontinuation. | Posted | Number | participants | Day 1 to Month 12 post transplantation |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Acute Rejection of Transplant up to End of Month 48 Post Transplantation - Intent to Treat Population in Long Term Extension | AR defined as a clinicopathological event requiring clinical evidence and biopsy confirmation by central pathologist. One or more conditions were met and a renal biopsy revealed histologic evidence of rejection: unexplained rise of serum creatine (SCr) >= 25 % from baseline plus one or more of the following: unexplained decreased urine output; fever and graft tenderness; a SCr that remained elevated within 14 days after transplantation and clinical suspicion of AR; reason other than those listed and participant was treated for this episode. Day 1 was day of transplantation. Banff grade used Banff 97 working classification of kidney transplant pathology. ITT population was all randomized and transplanted participants. | All participants who completed the short term (ST) period, were eligible and accepted to enter the LTE by signing a new informed consent form. | Posted | Number | participants | End of Month 12 to end of Month 48 Post Transplantation |
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| Secondary | Number of Participants With Graft Loss or Death at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | Graft loss was defined as either functional loss or physical loss. Functional loss was defined as either: sustained level of SCr greater than or equal to (>=) 6.0 mg/dL (530 micromoles/Liter; micromol/L) for >= 4 weeks as determined by the local laboratory; regularly scheduled dialysis treatments over a period of 56 days; impairment of renal function to such a degree that the participant undergoes re-transplant. Day 1 was day of transplantation. ITT population defined as all participants randomized and transplanted. | N=participants randomized and transplanted and in LTE. | Posted | Number | participants | End of Month 12 to end of Long Term Extension (Year 4) |
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| Secondary | Mean (Standard Deviation) in Calculated Glomerular Filtration Rate (GFR) mL/Min/1.73m^2 at Months 24, 36 and 48 Post Transplantation - Intent to Treat Population in Long Term Extension | GFR was calculated based upon serum creatinine (SCr) using the Modification of Diet in Renal Disease (MDRD) formula as suggested by Levey et al: MDRD GFR = 170 x [SCr/0.95]^(-0.999) x [Age]^(-0.176) x [0.762 if participant was female] x [1.180 if participant was black] x [BUN]^(-0.170) x [Alb]^(+0.318). Age in years, Alb = Albumin in g/dL; SCr = in mg/dL; BUN =Blood urea nitrogen in mg/dL. Intent to Treat population is defined as all participants randomized and transplanted. | N=All participants who were randomized, transplanted, in the LTE and had data available at the specific time point. | Posted | Mean | Standard Deviation | mL/Min/1.73m^2 | Months 24, 36 and 48 post transplantation |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Corticosteroid-free Participants at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | In the LTE, a participant was considered corticosteroid-free if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. | N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed. | Posted | Number | participants | End of Month 12 to end of Long Term Extension (Year 4) |
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| Secondary | Number of Participants Who Were Both Calcineurin Inhibitor-free (CNI-free)and Corticosteroid-free at Months 24, 36, 48 Post Transplantation - Intent to Treat Population in Long Term Extension | Participants were considered corticosteroid-free at Months 24, 36, and 48 if they were not receiving corticosteroids for >7 consecutive days during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants were considered CNI-free at Months 24, 36, and 48 if they were not receiving CNI during Day 701 and Day 756, Day 1065 and Day 1120, as well as Day 1429 and Day 1484, respectively. Participants in the tacrolimus arm were not relevant to this analysis because tacrolimus is a calcinurin inhibitor. | N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form, and had data available at the specific time point were analyzed. | Posted | Number | participants | Months 24, 36, 48 |
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| Secondary | Number of Participants Who Switched Between MMF and Sirolimus During Long Term Extension up to Study Completion | Long Term extension was the period from the end of Month 12 to the end of Month 48 post transplantation and the completion of the study 31 July 2012. At any time in the study, participants who were unable to tolerate MMF in the Bela-MMF and Tac-MMF groups could discontinue (DC) MMF and switch to sirolimus and remain in the study and those in the Bela-Siro group who were unable to tolerate sirolimus could DC sirolimus and switch to MMF and remain in the study. Study completion=data base (DB) lock. | N= All participants who completed the ST period, were eligible and accepted to enter the LTE by signing a new informed consent form | Posted | Number | participants | End of Month 12 to end of Study (Month 48) |
|
From Day 1 to end of 48 Months post transplantation and study closure
Total population of randomized participants in both short term period and long term extension.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Belatacept - MMF | 25 | 33 | 33 | 33 | |||
| EG001 | Belatacept - SIRO | 19 | 26 | 26 | 26 | |||
| EG002 | Tacrolimus - MMF | 22 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Graft loss | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal artery thrombosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Splenic abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary fistula | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Enterococcal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperpyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Embolism venous | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Encephalitis herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Secondary amyloidosis | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Benign neoplasm of thyroid gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Device malfunction | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Encephalitis fungal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nephropathy toxic | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection pseudomonal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal amyloidosis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Meningitis cryptococcal | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Mitral valve stenosis | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia klebsiella | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Graft dysfunction | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urine output decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperparathyroidism tertiary | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Scrotal oedema | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Parathyroid gland enlargement | Endocrine disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Renal bruit | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Bloody discharge | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Post procedural discharge | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| BK virus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
Main limitations of this study include: small size (small number of participants in each treatment arm), the open-label nature of the trial, its exploratory nature, and the high rate of switches from sirolimus to MMF in one of the belatacept groups.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.com |
| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D000069594 | Abatacept |
| D020123 | Sirolimus |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Death |
|
| No longer met criteria |
|
| Subject Request or refused |
|
| Poor non-compliance |
|
| non-specified |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Europe |
|
|
| Mild Acute IB |
|
| Moderate Acute IIA |
|
| Moderate Acute IIB |
|
Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF. |
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| Tacrolimus, MMF |
Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| Tacrolimus, MMF |
Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG001 | Belatacept, Sirolimus | Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF. |
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF. |
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
|
|
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
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Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
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| OG002 | Tacrolimus, MMF | Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID. |
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