Comparison · NCT02506153-sae
FDA Approved Regimen vs MK-3475 (Pembrolizumab): 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. FDA Approved Regimen vs MK-3475 (Pembrolizumab): serious adverse events. Trial comparisons, record NCT02506153-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02506153-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 | 0.0407 | 0.0273 | 0.0603 | wilson | |
| Risk in group 2 | 0.196 | 0.167 | 0.228 | wilson | |
| Risk difference, group 1 minus group 2 | -0.155 | -0.19 | -0.12 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.208 | 0.135 | 0.32 | log | |
| Odds ratio, group 1 over group 2 | 0.174 | 0.11 | 0.277 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FDA Approved Regimen than on MK-3475 (Pembrolizumab) | 6.46 | 5.26 | 8.34 | from the risk difference interval |
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 | FDA Approved Regimen | Participants receive physician/patient choice of either high-dose recombinant interferon alfa-2B (HD-IFN) or Ipilimumab as follows:~HD-IFN Induction: IV over 20 mins on days 1-5. Tx repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.~Maintenance: SC on days 1, 3, and 5. Tx repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity.~Ipilimumab Induction: IV over 90 mins on day 1. Tx repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity.~Maintenance: IV over 90 mins on day 1. Tx repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity.~89 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality at Risk population. | 23 | 565 | EG000 |
| Group 2 | MK-3475 (Pembrolizumab) | Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.~8 participants did not receive ant protocol treatment and were not evaluable for adverse events, however they were included in the All-Cause Mortality at Risk population. | 125 | 639 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomized patients will be followed until death or 94 months (from study start November 10, 2015 to September 15, 2023), whichever occurs first.
Source ClinicalTrials.gov
Trial
- Title
Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery
- NCT number
- NCT02506153
- Phases
- PHASE3
- Conditions
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Mucosal Melanoma, Metastatic Non-Cutaneous Melanoma, Non-Cutaneous Melanoma, Recurrent Cutaneous Melanoma, Recurrent Mucosal Melanoma, Recurrent Non-Cutaneous Melanoma
- Interventions
- Biospecimen Collection, Computed Tomography, Ipilimumab, Magnetic Resonance Imaging, Pembrolizumab, Positron Emission Tomography, Quality-of-Life Assessment, Recombinant Interferon Alfa-2b
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2024-08-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02506153?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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