Comparison · NCT03816332-sae
Nivolumab, Tacrolimus, and Prednisone vs Ipilimumab, Nivolumab, Tacrolimus, and Prednisone: 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. Nivolumab, Tacrolimus, and Prednisone vs Ipilimumab, Nivolumab, Tacrolimus, and Prednisone: serious adverse events. Trial comparisons, record NCT03816332-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03816332-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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 1 | 0.61 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.4 | -0.687 | 0.054 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.362 | 0.995 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on Nivolumab, Tacrolimus, and Prednisone than on Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | 2.5 | 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 | Nivolumab, Tacrolimus, and Prednisone | Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, and nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity. | 6 | 10 | EG000 |
| Group 2 | Ipilimumab, Nivolumab, Tacrolimus, and Prednisone | Patients received low-dose tacrolimus (serum trough goal 2-5 ng/mL), prednisone 5mg by mouth once a day, nivolumab 3 mg/kg by infusion and ipilimumab 1 mg/kg by infusion every 3 weeks for 4 doses followed by maintenance nivolumab 480mg by infusion every 4 weeks for up to 96 weeks in the absence of disease progression or unacceptable toxicity. | 6 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 3 years
Source ClinicalTrials.gov
Trial
- Title
- Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers
- NCT number
- NCT03816332
- Phases
- PHASE1
- Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Metastatic Basal Cell Carcinoma, Metastatic Melanoma, Metastatic Merkel Cell Carcinoma, Metastatic Skin Squamous Cell Carcinoma, Pathologic Stage III Cutaneous Melanoma AJCC v8, Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIA Cutaneous Melanoma AJCC v8, Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8, Unresectable Basal Cell Carcinoma, Unresectable Melanoma, Unresectable Merkel Cell Carcinoma
- Interventions
- Ipilimumab, Nivolumab, Prednisone, Tacrolimus
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2023-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03816332?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03816332-sae