A Phase 4 interventional study of Daclizumab and Methylprednisolone in Heart Transplantation, sponsored by Hoffmann-La Roche. Completed at 30 sites in 4 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2016-06-13.
Sponsored by Hoffmann-La Roche · Phase 4, Interventional, and Treatment
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.
Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Daclizumab · Drug: Methylprednisolone · Drug: Mycophenolate mofetil · Drug: cyclosporine
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.
Drug: Methylprednisolone · Drug: Mycophenolate mofetil · Drug: Placebo · Drug: cyclosporine
Daclizumab will be administered as 1 mg/kg IV within 12 hours post-op (Day 1), and Days 8, 22, 36 and 50.
Also known as: Zenapax
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 will be administered as 1.5 grams bid begun post-op, either IV or orally as required up to 365 days.
Matching placebo will be administered on Days 1, 8, 22, 36, and 50.
Cyclosporine will be administered as 1-4 mg/kg IV or 2-6 mg/kg orally up to 365 days.
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.
Time frame: Up to 6 months PT
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Day -2) to 3 months and 6 months
Median Change From Baseline for LDL/HDL Ratio
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
The study was conducted across 31 centers in four countries from 28 Aug 1999 to 19 Aug 2002.
| Milestone | Daclizumab | Placebo |
|---|---|---|
| Started | 216 | 218 |
| Completed | 165 | 170 |
| Not completed | 51 | 48 |
| Withdrew: Administration/other | 8 | 8 |
| Withdrew: Abnormality of laboratory test | 1 | 0 |
| Withdrew: Adverse event/intermittent illness | 14 | 11 |
| Withdrew: Death | 12 | 6 |
| Withdrew: Insufficient therapy | 1 | 4 |
| Withdrew: Other violation | 4 | 6 |
| Withdrew: Refused treatment | 5 | 5 |
| Withdrew: Violation criteria | 0 | 2 |
| Withdrew: Did not receive study drug | 6 | 6 |
| Milestone | Daclizumab | Placebo |
|---|---|---|
| Started | 165 | 170 |
| Completed | 162 | 167 |
| Not completed | 3 | 3 |
| Withdrew: Administration/other | 0 | 2 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Did not co-operate/withdrew | 1 | 0 |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant | 77 | 104 |
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
| participants | Daclizumab | Placebo |
|---|---|---|
| Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT | 97 | 116 |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| Within 6 months, 0 episode | 139 | 114 |
| Within 6 months, 1 episode | 63 | 82 |
| Within 6 months, 2 episodes | 12 | 19 |
| Within 6 months, 3 episodes | 2 | 2 |
| Within 6 months, 4 episodes | 0 | 1 |
| Within 12 months, 0 episode | 119 | 102 |
| Within 12 months, 1 episode | 68 | 90 |
| Within 12 months, 2 episodes | 23 | 19 |
| Within 12 months, 3 episodes | 3 | 5 |
| Within 12 months, 4 episodes | 3 | 2 |
The survival of the graft and participants at 6,12 months and 3 years PT was reported
| participants | Daclizumab | Placebo |
|---|---|---|
| Within 6 months | 16 | 10 |
| Within 12 months | 21 | 12 |
| Within 3 years | NA | NA |
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
| participants | Daclizumab | Placebo |
|---|---|---|
| Within 6 months, Grade 0 | 9 | 5 |
| Within 6 months, Grade IA | 64 | 51 |
| Within 6 months, Grade IB | 26 | 28 |
| Within 6 months, Grade II | 55 | 38 |
| Within 6 months, Grade IIIA | 48 | 74 |
| Within 6 months, Grade IIIB | 8 | 15 |
| Within 6 months, Grade IV | 1 | 1 |
| Within 12 months, Grade 0 | 7 | 4 |
| Within 12 months, Grade IA | 56 | 39 |
| Within 12 months, Grade IB | 22 | 21 |
| Within 12 months, Grade II | 51 | 47 |
| Within 12 months, Grade IIIA | 63 | 85 |
| Within 12 months, Grade IIIB | 11 | 15 |
| Within 12 months, Grade IV | 1 | 1 |
The median time to first acute rejection episode within first 6 months and 12 months PT was reported.
| days | Daclizumab | Placebo |
|---|---|---|
| Within 6 months (n= 77, 104) | 61 (2 to 210) | 21 (1 to 240) |
| Within 12 months (n=97, 116) | 96 (2 to 372) | 26 (1 to 377) |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| Within 6 months | 17 | 19 |
| Within 12 months | 23 | 21 |
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.
| mg | Daclizumab | Placebo |
|---|---|---|
| MMF dose, 6 months PT (n=193, 201) | 2522.2 ± 791 | 2450 ± 748.9 |
| MMF dose,12 months PT (n=188, 194) | 2394.1 ± 808 | 2380.1 ± 779.2 |
| IV Cyclosporine dose, 6 months PT (n=2, 1) | 86.11 ± 102.7 | 38.1 ± NA |
| IV Cyclosporine dose, 12 months PT (n=4, 2) | 93.5 ± 84.3 | 46.7 ± 18 |
| PO/NG Cyclosporine dose, 6 months PT (n=184, 182) | 321.9 ± 106.6 | 331.1 ± 121.7 |
| PO/NG Cyclosporine dose, 12 months PT (n=170, 170) | 294.7 ± 93.8 | 305.7 ± 116.6 |
| Cumulative corticosteroids,6 months PT(n=203, 206) | 848.1 ± 402 | 955.4 ± 442.8 |
| Cumulative corticosteroids,12 months PT(n=195,200) | 1199.6 ± 771.8 | 1288.9 ± 796.1 |
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.
| mg/dL | Daclizumab | Placebo |
|---|---|---|
| Total cholesterol, change at 3 months (n=119,119) | 0.65 (-3.23 to 5.69) | 0.91 (-2.20 to 4.53) |
| Total cholesterol, change at 6 months (n=126,130) | 0.28 (-3.75 to 6.59) | 0.61 (-2.72 to 6.39) |
| LDL, Change at 3 months (n=92,89) | 0.25 (-3.35 to 4.84) | 0.34 (-2.47 to 3.48) |
| LDL, Change at 6 months (n=91,99) | 0.03 (-2.86 to 3.98) | 0.21 (-2.70 to 3.48) |
| HDL, change at 3 months (n=97, 101) | 0.34 (-1.27 to 1.72) | 0.31 (-1.48 to 1.64) |
| HDL, change at 6 months (n=102,112) | 0.23 (-1.53 to 1.69) | 0.20 (-1.30 to 1.17) |
| Triglycerides,change at 3 months (n=104,108) | 0.26 (-9.42 to 3.71) | 0.46 (-12.5 to 7.84) |
| Triglycerides,change at 6 months (n=109,117) | 0.20 (-6.48 to 8.48) | 0.44 (-11.3 to 7.21) |
| LDL/HDL ratio,change at 3 months (n=91,89) | -0.44 (-4.33 to 9.41) | -0.12 (-6.73 to 3.53) |
| LDL/HDL ratio,change at 6 months (n=91, 99) | -0.50 (-4.45 to 3.83) | -0.14 (-6.01 to 2.90) |
| ratio | Daclizumab | Placebo |
|---|---|---|
| LDL/HDL ratio,change at 3 months (n=91,89) | -0.44 (-4.33 to 9.41) | -0.12 (-6.73 to 3.53) |
| LDL/HDL ratio,change at 6 months (n=91, 99) | -0.50 (-4.45 to 3.83) | -0.14 (-6.01 to 2.90) |
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
| participants | Daclizumab | Placebo |
|---|---|---|
| Hematocrit-high (n=210, 203) | 0 | 0 |
| Hematocrit-low (n=210, 203) | 116 | 117 |
| Hemoglobin-high (n=210, 204) | 0 | 0 |
| Hemoglobin-low (n=210, 204) | 107 | 112 |
| Platelets-high (n=210, 203) | 2 | 1 |
| Platelets-low (n=210, 203) | 30 | 22 |
| RBC-high (n=209, 203) | 1 | 2 |
| RBC-low (n=209, 203) | 116 | 106 |
| Basophils-high (n=199, 195) | 4 | 4 |
| Eosinophils-high (n=199, 195) | 0 | 0 |
| Lymphocytes-high (n=199, 198) | 2 | 2 |
| Lymphocytes-low (n=199, 198) | 157 | 157 |
| Monocytes-high (n=199, 198) | 5 | 6 |
| Monocytes-low (n=199, 198) | 14 | 20 |
| Neutrophils-low (n= 199, 198) | 33 | 33 |
| WBC-high (n=207, 201) | 61 | 57 |
| WBC-low (n=207, 201) | 43 | 29 |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| SGPT-high (n=200, 200) | 48 | 45 |
| ALP-high (n=201, 200) | 15 | 7 |
| SGOT-high (n=201, 200) | 22 | 25 |
| GGT-high (n=180, 175) | 90 | 74 |
| LDH-high (n=194, 191) | 53 | 54 |
| Total bilirubin-high (n=201, 200) | 28 | 20 |
| BUN-high (n= 210, 200) | 93 | 95 |
| Creatinine-high (n=211, 203) | 66 | 64 |
| Albumin-low (n=198,197) | 47 | 50 |
| Total protein-high (n=195,196) | 5 | 0 |
| Total protein-low(n=195,196) | 85 | 79 |
| Cholesterol-high (n=174, 174) | 3 | 4 |
| Triglycerides-high (n=164, 164) | 35 | 30 |
| Carbondioxide-high (n=206, 197) | 27 | 21 |
| Carbondioxide-low (n=206, 197) | 12 | 5 |
| Chloride-high (n=211, 203) | 1 | 3 |
| Chloride-low (n=211, 203) | 42 | 36 |
| Potassium-high (n=211, 204) | 7 | 7 |
| Potassium-low (n=211, 204) | 4 | 2 |
| Sodium-high (n=211, 203) | 2 | 1 |
| Sodium-low (n=211, 203) | 8 | 11 |
| Calcium-low (n=207, 201) | 39 | 44 |
| Glucose fasting-high (n=210, 203) | 28 | 27 |
| Glucose fasting-low (n=210, 203) | 3 | 3 |
| Phosphate-high (n=199, 194) | 54 | 48 |
| Phosphate-low (n=199,194) | 32 | 26 |
| Uric acid high (n=191, 188) | 23 | 20 |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| Any AEs | 214 | 207 |
| Any SAE's | 108 | 102 |
| Any AEs leading to premature discontinuation | 14 | 11 |
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.
| participants | Daclizumab | Placebo |
|---|---|---|
| Participants with malignancies | 11 | 11 |
| Participants with opportunistic infections | 71 | 80 |
Collected over Up to 12 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Daclizumab | — | 108/216 (50%) | 210/216 (97.2%) |
| Placebo | — | 102/207 (49.3%) | 204/207 (98.6%) |
| Event | Daclizumab | Placebo |
|---|---|---|
| Renal failure acuteRenal and urinary disorders | 2/216 | 8/207 |
| Cardiac arrestCardiac disorders | 6/216 | 7/207 |
| Sepsis nosInfections and infestations | 7/216 | 4/207 |
| Pericardial effusionCardiac disorders | 6/216 | 4/207 |
| Pneumonia nosInfections and infestations | 6/216 | 5/207 |
| Wound infection necInfections and infestations | 6/216 | 2/207 |
| Atrial flutterCardiac disorders | 2/216 | 5/207 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 5/216 | 4/207 |
| Multi-organ failureGeneral disorders | 1/216 | 4/207 |
| Pneumothorax nosRespiratory, thoracic and mediastinal disorders | 2/216 | 4/207 |
| Event | Daclizumab | Placebo |
|---|---|---|
| Hypertension nosVascular disorders | 119/216 | 131/207 |
| Post procedural painInjury, poisoning and procedural complications | 106/216 | 105/207 |
| NauseaGastrointestinal disorders | 88/216 | 101/207 |
| InsomniaPsychiatric disorders | 82/216 | 81/207 |
| ConstipationGastrointestinal disorders | 81/216 | 80/207 |
| Hyperglycaemia nosMetabolism and nutrition disorders | 58/216 | 72/207 |
| TremorNervous system disorders | 62/216 | 67/207 |
| Anaemia nosBlood and lymphatic system disorders | 64/216 | 52/207 |
| Headache nosNervous system disorders | 64/216 | 58/207 |
| Oedema lower limbGeneral disorders | 58/216 | 60/207 |
The randomized population included all participants who were randomized into the study, whether they received the study drug or not.
| Age, Continuous(years) | Daclizumab | Placebo | Total |
|---|---|---|---|
| Mean | 52.4 ± 11.75 | 53.1 ± 11.89 | 52.8 ± 11.81 |
| Sex: Female, Male(Participants) | Daclizumab | Placebo | Total |
|---|---|---|---|
| Female | 45 | 41 | 86 |
| Male | 171 | 177 | 348 |
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Hoffmann-La Roche