Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.
This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tacrolimus/MMF/Basiliximab | Active Comparator | Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. |
|
| Alefacept QW/Tacrolimus/MMF | Experimental | Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. |
|
| Alefacept QW/Tacrolimus | Experimental | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
|
| Alefacept QOW/Tacrolimus/MMF | Experimental | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alefacept | Drug | Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival at Month 6 and Month 12 | Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of < 250 cells/µL
Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours
Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
| Principal Investigator | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States | ||
| University of Southern California - University Hospital |
Not provided
This study enrolled de novo kidney transplant recipients who were at least 18 years of age.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus/MMF/Basiliximab | Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| tacrolimus | Drug | The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations. |
|
|
| basiliximab | Drug | Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3. |
|
|
| mycophenolate mofetil | Drug | Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms. |
|
|
| Corticosteroids | Drug | Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol. |
|
| Graft Survival at Month 6 and Month 12 | Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
| Percentage of Participants With BCAR at Month 12 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 12 months |
| Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
| Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
| Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
| Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method. | Week 4, Month 6 and Month 12 |
| Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | The glomerular filtration rate was measured directly using iothalamate clearance. | Week 4 and Month 6 |
| Change From Week 4 in Serum Creatinine at Month 6 and 12 | Week 4 and Month 6 and 12 |
| Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up. | 6 months and 12 months |
| Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up. | 6 months and 12 months |
| Time to First BCAR Assessed by Local Review | The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. | 12 months |
| Time to First BCAR Assessed by Central Review | The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. | 12 months |
| Time to First T-cell Mediated BCAR Assessed by Local Review | The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. | 12 months |
| Time to First T-cell Mediated BCAR Assessed by Central Review | The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis. | 12 months |
| Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. | 6 months and 12 months |
| Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. | 6 months and 12 months |
| Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection. | 6 months and 12 months |
| Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol. The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event. | 6 months and 12 months |
| Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months. | 6 months and 12 months |
| Percentage of Participants With Treatment Failure at Month 6 and 12 | Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | 6 months and 12 months |
| Gastrointestinal Quality of Life Index Score Over Time | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria. | Months 1, 3, 6, and 12 |
| Gastrointestinal Symptom Rating Scale Scores Over Time | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. | Months 1, 3, 6, and 12 |
| Los Angeles |
| California |
| 90033 |
| United States |
| St. Vincent/National Institute of Transplantation | Los Angeles | California | 90057 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| UCSD | San Diego | California | 92103 | United States |
| California Institute of Renal Research/Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| University of California - San Francisco | San Francisco | California | 94143 | United States |
| University of Colorado Health Science Center | Aurora | Colorado | 80045 | United States |
| University of Florida, Shands Hospital, Gainesville | Gainesville | Florida | 32610 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Medical College of Georgia, Augusta | Augusta | Georgia | 30921 | United States |
| Rush - Presbyterian - St. Lukes Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Maryland Center | Baltimore | Maryland | 21201 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St. Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| Mt. Sinai School of Medicine | New York | New York | 10029 | United States |
| New York Presbyterian Hospital - Cornell | New York | New York | 10065 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University Hospital of Cleveland | Cleveland | Ohio | 44106 | United States |
| Legacy Transplant Services | Portland | Oregon | 97210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Pinnacle Health at Harrisburg | Harrisburg | Pennsylvania | 17101 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Methodist University Hospital - Memphis | Memphis | Tennessee | 38104 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| Methodist Hospital Research Institute of Houston | Houston | Texas | 77030 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 23298 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | United States |
| Alefacept QW/Tacrolimus/MMF |
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. |
| FG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| FG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus/MMF/Basiliximab | Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. |
| BG001 | Alefacept QW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. |
| BG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| BG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Survival at Month 6 and Month 12 | Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Graft Survival at Month 6 and Month 12 | Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BCAR at Month 12 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review | Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review | Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review | Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12 | The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method. | Full analysis set with available data at Week 4. "N" indicates the number of participants with available data at each time point. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Week 4, Month 6 and Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 4 in GFR by Iothalamate Clearance at Month 6 | The glomerular filtration rate was measured directly using iothalamate clearance. | Full analysis set with available data at Week 4. "N" indicates participants with available data at Week 4 and Month 6. | Posted | Mean | Standard Deviation | mL/min per 1.73 m^2 | Week 4 and Month 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 4 in Serum Creatinine at Month 6 and 12 | Full analysis set with available data at Week 4. "N" indicates participants with available data at each time point. | Posted | Mean | Standard Deviation | mg/dL | Week 4 and Month 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review | Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to local review, or lost to follow-up. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review | Efficacy failure is defined as death, graft failure (permanent return to dialysis [>30 days] or retransplant), BCAR according to central review, or lost to follow-up. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First BCAR Assessed by Local Review | The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. | Full analysis set with a BCAR assessed by local review | Posted | Median | Full Range | days | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First BCAR Assessed by Central Review | The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis. | Full analysis set with a BCAR as assessed by the central reviewer | Posted | Median | Full Range | days | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First T-cell Mediated BCAR Assessed by Local Review | The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. | Full analysis set with a T-cell mediated BCAR as assessed by local review | Posted | Median | Full Range | days | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First T-cell Mediated BCAR Assessed by Central Review | The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis. | Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer | Posted | Median | Full Range | days | 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Grade of T-cell Mediated Rejection Assessed by Local Review | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. | Full analysis set | Posted | Number | participants | 6 months and 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review | The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis. Grade IA: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising >25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation. | Full analysis set | Posted | Number | participants | 6 months and 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12 | Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12 | Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol. The use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12 | All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Treatment Failure at Month 6 and 12 | Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit. | Full analysis set | Posted | Number | 90% Confidence Interval | percentage of participants | 6 months and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Gastrointestinal Quality of Life Index Score Over Time | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria. | Full analysis set with available data at each time point (indicated by "N") | Posted | Mean | Standard Deviation | units on a scale | Months 1, 3, 6, and 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Gastrointestinal Symptom Rating Scale Scores Over Time | The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. | Full analysis set with available data at each time point (indicated by "N") | Posted | Mean | Standard Deviation | units on a scale | Months 1, 3, 6, and 12 |
|
12 months
Not provided
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 | Tacrolimus/MMF/Basiliximab | Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months. | 41 | 79 | 79 | 79 | ||
| EG001 | Alefacept QW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months. | 48 | 77 | 77 | 77 | ||
| EG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. | 40 | 75 | 75 | 75 | ||
| EG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. | 45 | 78 | 78 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urosepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Viraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Polyomavirus-Associated Nephropathy | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Aspergillosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Cytomegaloviral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Staphylococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Arteriovenous Graft Site Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Bacterial Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| BK Virus Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchopulmonary Aspergillosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Related Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis Enterococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis Of Male External Genital Organ | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis Staphylococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Clostridial Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Gastritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Disseminated Cryptococcosis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Enterococcal Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Epstein-Barr Viraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Fungal Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Helicobacter Gastritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Incision Site Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Intertrigo Candida | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Meningitis Cryptococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Oesophageal Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Perinephric Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Peritonitis Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Herpes Viral | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Mycoplasmal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia Pneumococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Retroperitoneal Abscess | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis Syndrome | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Skin Bacterial Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Streptococcal Bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Streptococcal Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Ureteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Pseudomonal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound Infection Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Complications Of Transplanted Kidney | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Perirenal Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post Procedural Urine Leak | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Graft Thrombosis | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Incision Site Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Lymphocele | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Transplant Failure | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Haematoma | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Colitis Ischaemic | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erosive Duodenitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Reflux Oesophagitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Vein Thrombosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ureteric Obstruction | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Focal Glomerulosclerosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nephritis Interstitial | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Obstructive Uropathy | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Artery Stenosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Artery Thrombosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Mass | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Vasculitis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tubulointerstitial Nephritis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Histology Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Immunosuppressant Drug Level Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Oxygen Saturation Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertensive Crisis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral Artery Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renovascular Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Subclavian Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Flutter | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Tamponade | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Ischaemia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sick Sinus Syndrome | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lymphadenopathy Mediastinal | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Splenic Infarction | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Obstructive Airways Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Papillary Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Thyroid Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Anoxic Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetic Neuropathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope Vasovagal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Unresponsive To Stimuli | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Removal Of Renal Transplant | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Arteriovenous Fistula Operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Pancreas Transplant | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhagic Ovarian Cyst | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Septal Defect | Congenital, familial and genetic disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Parathyroid Gland Enlargement | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Serum Sickness | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Polycythaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Generalised Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Impaired Healing | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| BK Virus Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Candiduria | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Cytomegalovirus Viraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Escherichia Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Oral Candidiasis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Bacterial | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Complications Of Transplanted Kidney | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Incision Site Complication | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Perinephric Collection | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post Procedural Discharge | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Therapeutic Agent Toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Wound Secretion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Magnesium Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Urea Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| CD4 Lymphocytes Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Immunosuppressant Drug Level Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine Output Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Vitamin D Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bladder Spasm | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Scrotal Oedema | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Orthostatic Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Standard Restriction Description: Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 12 months after data-lock, whichever is first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Head Global Medical Sciences--Transplant and Immunology/Inflammation | Astellas Pharma Global Development, Inc. (APGD) | Astellas.resultsdisclosure@astellas.com |
| ID | Term |
|---|---|
| D000077944 | Alefacept |
| D016559 | Tacrolimus |
| D000077552 | Basiliximab |
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D018968 | CD58 Antigens |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008565 | Membrane Proteins |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
| Male |
|
| Difference | 6.1 | 2-Sided | 90 | -3.6 | 15.8 | A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1). | Yes | Non-Inferiority or Equivalence | The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen. |
| Difference | 4.0 | 2-Sided | 90 | -5.3 | 13.3 | A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1). | Yes | Non-Inferiority or Equivalence | The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen. |
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| Alefacept QW/Tacrolimus |
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG002 |
| Alefacept QW/Tacrolimus |
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG002 |
| Alefacept QW/Tacrolimus |
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG002 |
| Alefacept QW/Tacrolimus |
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
|
| OG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|
| OG002 | Alefacept QW/Tacrolimus | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months. |
| OG003 | Alefacept QOW/Tacrolimus/MMF | Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months. |
|
|