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The purpose of the study is to compare the number of randomized participants in each treatment group who experience an acute rejection episode in the first 6 months after undergoing cardiac transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daclizumab | Experimental | Daclizumab will be administered as a intravenous dose of 1 milligrams per kilogram [mg/kg] on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg, and 500-1000 mg IV methylprednisolone peri operative switch to oral at 0.5-1 mg/kg/day followed by tapering. |
|
| Placebo | Placebo Comparator | Matching placebo will be administered on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine 1-4 mg/kg IV or 2-6 mg/kg orally, and 500-1000 mg IV methylprednisolone peri-op switch to oral at 0.5-1 mg/kg/day followed by tapering. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclizumab | Drug | Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up. | Up to 6 months PT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-0006 | United States | |||
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The study was conducted across 31 centers in four countries from 28 Aug 1999 to 19 Aug 2002.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daclizumab | Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Completed 6 Months Study |
|
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| Methylprednisolone | Drug | Methylprednisolone will be administered as 500-1000 mg IV and peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering till 0.0-0.15 mg/kg/day (up to 365 days). |
|
| Mycophenolate mofetil | Drug | Mycophenolate mofetil will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days. |
|
| Placebo | Drug | Matching placebo will be administered on Days 1, 8, 22, 36, and 50. |
|
| cyclosporine | Drug | Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days. |
|
| Up to 12 months PT |
| Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first. | Within 6 months and 12 months PT |
| Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT | The survival of the graft and participants at 6,12 months and 3 years PT was reported | At 6 months, 12 months , 3 years PT |
| Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT | The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis | Within 6 months and 12 months PT |
| Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT | The median time to first acute rejection episode within first 6 months and 12 months PT was reported. | Within 6 months and 12 months PT |
| Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT | The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported. | Within 6 months and 12 months PT |
| Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT | The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval. | Within 6 months and 12 months PT |
| Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides) | Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported. | From Baseline (Day -2) to 3 months and 6 months |
| Median Change From Baseline for LDL/HDL Ratio | From Baseline (Day -2) to 3 months, and 6 months |
| Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters | A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count | Up to 12 months |
| Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters | A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides. | Up to 12 months |
| Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to 12 months |
| Number of Participants With Malignancies and Opportunistic Infections | The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported. | Up to 12 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| Tampa | Florida | 33606 | United States |
| Louisville | Kentucky | 40202 | United States |
| Baltimore | Maryland | 21287 | United States |
| Boston | Massachusetts | 02111 | United States |
| Boston | Massachusetts | 02115 | United States |
| Ann Arbor | Michigan | 48109-0366 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| New York | New York | 10032 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45267-0542 | United States |
| Cleveland | Ohio | 44195 | United States |
| Portland | Oregon | 97201 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Pittsburgh | Pennsylvania | 15213-2582 | United States |
| Charleston | South Carolina | 29425-2221 | United States |
| Dallas | Texas | 75230 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77030 | United States |
| Salt Lake City | Utah | 84132 | United States |
| Madison | Wisconsin | 53792 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
| London | Ontario | N6A 5A5 | Canada |
| Ottawa | Ontario | K1Y 4W7 | Canada |
| Frankfurt am Main | 60590 | Germany |
| Hanover | 30625 | Germany |
| Gothenburg | 41345 | Sweden |
| FG001 | Placebo | Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Completed 12 Months Study |
|
|
The randomized population included all participants who were randomized into the study, whether they received the study drug or not.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Daclizumab | Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
| BG001 | Placebo | Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
| BG002 | 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 | Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | Up to 6 months PT |
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| Secondary | Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | Up to 12 months PT |
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| Secondary | Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT | The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | Within 6 months and 12 months PT |
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| Secondary | Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT | The survival of the graft and participants at 6,12 months and 3 years PT was reported | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | At 6 months, 12 months , 3 years PT |
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| Secondary | Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT | The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | Within 6 months and 12 months PT |
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| Secondary | Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT | The median time to first acute rejection episode within first 6 months and 12 months PT was reported. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'. | Posted | Median | Full Range | days | Within 6 months and 12 months PT |
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| Secondary | Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT | The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Number | participants | Within 6 months and 12 months PT |
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| Secondary | Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT | The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'. | Posted | Mean | Standard Deviation | mg | Within 6 months and 12 months PT |
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| Secondary | Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides) | Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported. | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'. | Posted | Median | Full Range | mg/dL | From Baseline (Day -2) to 3 months and 6 months |
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| Secondary | Median Change From Baseline for LDL/HDL Ratio | The randomized population included all participants who were randomized into the study, whether they received the study drug or not. | Posted | Median | Full Range | ratio | From Baseline (Day -2) to 3 months, and 6 months |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters | A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count | Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by 'n'. | Posted | Number | participants | Up to 12 months |
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| Secondary | Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters | A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides. | Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by 'n'. | Posted | Number | participants | Up to 12 months |
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| Secondary | Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). | Posted | Number | participants | Up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Malignancies and Opportunistic Infections | The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported. | Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). | Posted | Number | participants | Up to 12 months |
|
Up to 12 months
Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by 'n'.
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 | Daclizumab | Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. | 108 | 216 | 210 | 216 | ||
| EG001 | Placebo | Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. | 102 | 207 | 204 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coagulation disorder nos | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Leukopenia nos | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Arrhythmia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrioventricular block nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Bradycardia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cardiac failure nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Coronary artery disease nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Endocarditis nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Post myocardial infarction syndrome | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pulmonary oedema nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tachycardia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular arrhythmia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Antibiotic associated colitis | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Caecum perforation | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Food poisoning nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gastritis nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Intra-abdominal haemorrhage nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Mesenteric occlusion | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Oesophageal perforation | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Small intestinal perforation nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Toxic dilatation of colon | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Debility | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia nos | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Humoral immune defect | Immune system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Abscess nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Clostridial infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Empyema nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Gastroenteritis nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Gastroenteritis viral nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Interstitial pneumonia | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Pleural infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Pneumonia gram-negative bacterial nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Pneumonia nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Purulent pericarditis | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Sepsis nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Septicaemia staphylococcal | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Septicaemia streptococcal | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Upper respiratory tract infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Urinary tract infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Viral infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Wound infection nec | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Aortic injury | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Brain herniation | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Haemothorax | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Post procedural drainage | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Postoperative haematoma | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Therapeutic agent poisoning | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Traumatic chest injury nos | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Upper limb fracture nos | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Liver function tests nos abnormal | Investigations | MedDRA 4.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 4.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Diabetes mellitus nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hyperglycemia nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Muscle necrosis | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Myopathy steroid | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Adenoma benign nos | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.0 | Systematic Assessment |
| |
| Precancerous skin lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.0 | Systematic Assessment |
| |
| Anoxic encephalopathy | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Compartment syndrome | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Convulsions nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Encephalopathy nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Headache nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Intracranial haemorrhage nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Migraine nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Delirium tremens | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Depression nos | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Calculus renal nos | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Loin pain | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal failure nos | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal impairment nos | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Mediastinal haematoma | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Mediastinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Non-cardiogenic pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pneumothorax nos | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Respiratory failure (excl neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Arterial haemorrhage nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cerebellar infarction | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cerebral infarction | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cerebrovascular accident nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Deep venous thrombosis nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Haemorrhage nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypertension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypotension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Lymphorrhoea | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Peripheral vascular disorder nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pulmonary hypertension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Venous thrombosis deep limb | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Diaphragmatic paralysis | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Excessive bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia nos | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Leukopenia nos | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Arrhythmia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Bradycardia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Nodal arrhythmia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pericardial rub | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tachycardia nos | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular hypokinesia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Abdominal pain nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Diarrhoea nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gastrointestinal upset | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hiccups | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Vomiting nos | Gastrointestinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Oedema lower limb | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Oedema nos | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pain nos | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Rigors | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Bronchitis nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Pneumonia nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Upper respiratory tract infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Urinary tract infection nos | Infections and infestations | MedDRA 4.0 | Systematic Assessment |
| |
| Post procedural pain | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 4.0 | Systematic Assessment |
| |
| Liver function tests nos abnormal | Investigations | MedDRA 4.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 4.0 | Systematic Assessment |
| |
| Diabetes mellitus nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hyperglycaemia nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hyperlipidaemia nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypoglycaemia nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Metabolic acidosis nos | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Muscle cramps | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Peripheral swelling | Musculoskeletal and connective tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Dizziness (excl vertigo) | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Headache nos | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Anxiety nec | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Depression nos | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Renal impairment nos | Renal and urinary disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Breath sounds decreased | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Dyspnoea nos | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pneumothorax nos | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Acne nos | Skin and subcutaneous tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pressure sore | Skin and subcutaneous tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Rash nos | Skin and subcutaneous tissue disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypertension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Hypotension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Pulmonary hypertension nos | Vascular disorders | MedDRA 4.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 4.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 616878333 | global.trial_information@roche.com |
| ID | Term |
|---|---|
| D000077561 | Daclizumab |
| D008775 | Methylprednisolone |
| D009173 | Mycophenolic Acid |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
Not provided
Not provided
| Did not co-operate/Withdrew |
|
| Male |
|
Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
|
|
|
|
|
|
|
Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
|
|
|
|
|
|
|
| OG001 |
| Placebo |
Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
|
|
| OG001 | Placebo | Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
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| OG001 | Placebo | Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days. |
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