Comparison · NCT03020589-sae
CYP3A5 Based Tacrolimus Dosing vs Control: serious adverse events
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. CYP3A5 Based Tacrolimus Dosing vs Control: serious adverse events. Trial comparisons, record NCT03020589-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03020589-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 | 0.1 | 0.0396 | 0.231 | wilson | |
| Risk in group 2 | 0.0351 | 0.00968 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0649 | -0.0387 | 0.198 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.85 | 0.548 | 14.8 | log | |
| Odds ratio, group 1 over group 2 | 3.06 | 0.532 | 17.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CYP3A5 Based Tacrolimus Dosing than on Control | 15.4 | 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 | CYP3A5 Based Tacrolimus Dosing | Subjects in this treatment arm will receive initial tacrolimus based on their genotype i.e., CYP3A5\*1/\*1 and CYP3A5\*1/\*3 (Expressers) will receive the initial tacrolimus dose of 0.2 mg/kg/day, with maximum of 20 mg/day in 2 divided doses. For CYP3A5\*3/\*3 (Non-Expressers), the subjects will receive initial tacrolimus dose of 0.1 mg/kg/day in 2 divided doses.~Tacrolimus: See description in arm/group sections | 4 | 40 | EG000 |
| Group 2 | Control | Subjects in the prospective control group will receive standard tacrolimus dosing as recommended per package insert and will not be dosed based on their genotype. Similarly, subjects that underwent renal transplant after 2010 and received standard tacrolimus dosing (per package insert) will serve as historical controls. | 2 | 57 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events are reported from the study start through Study Day 365.
Source ClinicalTrials.gov
Trial
- Title
- Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
- NCT number
- NCT03020589
- Phases
- PHASE4
- Conditions
- Renal Transplant
- Interventions
- Tacrolimus
- Lead sponsor
- University of North Carolina, Chapel Hill
- Results first posted
- 2022-07-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03020589?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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