Comparison · NCT03284424-sae
Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: 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. Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: serious adverse events. Trial comparisons, record NCT03284424-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03284424-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 | 0.547 | 0.47 | 0.623 | wilson | |
| Risk in group 2 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | -0.119 | -0.402 | 0.346 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.821 | 0.364 | 1.85 | log | |
| Odds ratio, group 1 over group 2 | 0.604 | 0.0537 | 6.8 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course than on Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | 8.37 | 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 | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course | Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months). | 87 | 159 | EG000 |
| Group 2 | Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course | Eligible participants who stopped the initial course of pembrolizumab but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. | 2 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to approximately 56 months
Source ClinicalTrials.gov
Trial
- Title
- Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)
- NCT number
- NCT03284424
- Phases
- PHASE2
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Pembrolizumab
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2021-11-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03284424?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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