Comparison · NCT01950819-sae
Everolimus Plus@Reduced CNI vs MPA Plus Standard@CNI: 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 Plus@Reduced CNI vs MPA Plus Standard@CNI: serious adverse events. Trial comparisons, record NCT01950819-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01950819-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 | 0.585 | 0.554 | 0.615 | wilson | |
| Risk in group 2 | 0.606 | 0.575 | 0.635 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0209 | -0.0635 | 0.0218 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.965 | 0.899 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.917 | 0.768 | 1.09 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Everolimus Plus@Reduced CNI than on MPA Plus Standard@CNI | 47.8 | 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 | Everolimus Plus@Reduced CNI | Everolimus plus@reduced CNI | 593 | 1,014 | EG000 |
| Group 2 | MPA Plus Standard@CNI | MPA plus standard@CNI | 613 | 1,012 | 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 are reported in this record from First Patient First Treatment until Last Patient Last Visit up to approximately 4 years.
Source ClinicalTrials.gov
Trial
- Title
- Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)
- NCT number
- NCT01950819
- Phases
- PHASE4
- Conditions
- End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation
- Interventions
- Induction therapy, Corticosteroids, EVR+rCNI, MPA+sCNI
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2019-01-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01950819?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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