Comparison · NCT00533442-sae
Tacrolimus Plus MMF Plus Steroids vs Tacrolimus Plus Rapamycin Plus Steroids: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Tacrolimus Plus MMF Plus Steroids vs Tacrolimus Plus Rapamycin Plus Steroids: serious adverse events. Trial comparisons, record NCT00533442-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00533442-sae
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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 | 0.465 | 0.363 | 0.57 | wilson | |
| Risk in group 2 | 0.452 | 0.35 | 0.559 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0127 | -0.134 | 0.159 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.742 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.576 | 1.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tacrolimus Plus MMF Plus Steroids than on Tacrolimus Plus Rapamycin Plus Steroids | 78.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tacrolimus Plus MMF Plus Steroids | This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.~Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day | 40 | 86 | EG000 |
| Group 2 | Tacrolimus Plus Rapamycin Plus Steroids | Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.~Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.~Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:~10-15ng/ml)~Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day. | 38 | 84 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- during the first year post-transplant
Source ClinicalTrials.gov
Trial
- Title
- Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
- NCT number
- NCT00533442
- Phases
- PHASE2
- Conditions
- Type 1 Diabetes
- Interventions
- Rapamycin, Mycophenolate Mofetil, Tacrolimus, Steroids
- Lead sponsor
- University of Miami
- Results first posted
- 2017-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00533442?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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