Comparison · NCT00634920-sae
Everolimus (CNI-free) vs Control (CsA): 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. Everolimus (CNI-free) vs Control (CsA): serious adverse events. Trial comparisons, record NCT00634920-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00634920-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 | 0.706 | 0.611 | 0.786 | wilson | |
| Risk in group 2 | 0.65 | 0.553 | 0.736 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0559 | -0.0722 | 0.182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.897 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.715 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus (CNI-free) than on Control (CsA) | 17.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Everolimus (CNI-free) | This investigational drug was provided by Novartis. All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the everolimus group (CNI-free regimen) were treated with everolimus (Certican) EC MPS and corticosteroids. Patients randomized to this arm 7 weeks after renal transplantation will do an overnight switch from cyclosporine to everolimus. | 72 | 102 | EG001 |
| Group 2 | Control (CsA) | All patients received induction therapy with basiliximab, and commenced on an immunosuppressive regimen consisting of CsA, EC-MPS and corticosteroids before they were randomized. After randomization patients in the control group continued on the prior immunosuppressive regimen given before randomization. Conventional treatment arm with cyclosporine (CsA), mycophenolate (Myfortic) and corticosteroids continued for the entire 36 months study period. | 65 | 100 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients
- NCT number
- NCT00634920
- Phases
- PHASE4
- Conditions
- Renal Function
- Interventions
- everolimus, cyclosporine A, Enteric Coated Mycophenolate Sodium (EC-MPS), corticosteroids, Basiliximab
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2014-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00634920?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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