Comparison · NCT00862979-sae
CNI-regimen vs CNI-free-regimen: 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. CNI-regimen vs CNI-free-regimen: serious adverse events. Trial comparisons, record NCT00862979-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00862979-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 | 0.476 | 0.373 | 0.582 | wilson | |
| Risk in group 2 | 0.372 | 0.273 | 0.483 | wilson | |
| Risk difference, group 1 minus group 2 | 0.104 | -0.0472 | 0.249 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 0.889 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 1.54 | 0.82 | 2.88 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CNI-regimen than on CNI-free-regimen | 9.58 | 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 | CNI-regimen | CNI-regimen: cyclosporine A (CyA) or tacrolimus (TAC) with everolimus (EVR) with corticosteroids | 40 | 84 | EG000 |
| Group 2 | CNI-free-regimen | CNI-free regimen: MPA (either MMF or enteric coated mycophenolate sodium (EC-MPS)) and everolimus and corticosteroids; On month 6 to 9 only: Cyclosporin A or tacrolimus | 29 | 78 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Source ClinicalTrials.gov
Trial
- Title
- A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
- NCT number
- NCT00862979
- Phases
- PHASE4
- Conditions
- Heart Transplantation
- Interventions
- Everolimus (EVR), cyclosporine A (CyA), tacrolimus (TAC), Enteric coated mycophenolate sodium (EC-MPS), mycophenolate mofetil (MMF), Corticosteroids
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2018-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00862979?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00862979-sae