Comparison · NCT00048165-4835761c
Daclizumab vs Placebo: Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Daclizumab vs Placebo: Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT. Trial comparisons, record NCT00048165-4835761c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00048165-4835761c
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.449 | 0.384 | 0.516 | wilson | |
| Risk in group 2 | 0.532 | 0.466 | 0.597 | wilson | |
| Risk difference, group 1 minus group 2 | -0.083 | -0.175 | 0.0109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.844 | 0.696 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.717 | 0.491 | 1.05 | log | |
| Number needed to treat, for one fewer participant with the outcome on Daclizumab than on Placebo | 12 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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. | 97 | 216 | OG000 |
| Group 2 | 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. | 116 | 218 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT
- Description
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
- Population
- The randomized population included all participants who were randomized into the study, whether they received the study drug or not.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Zenapax in Combination With CellCept, Cyclosporine, and Corticosteroids in Patients Undergoing Cardiac Transplantation
- NCT number
- NCT00048165
- Phases
- PHASE4
- Conditions
- Heart Transplantation
- Interventions
- Daclizumab, Methylprednisolone, Mycophenolate mofetil, Placebo, cyclosporine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00048165?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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