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Comparison · NCT03284424-deaths

Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: deaths from any cause

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. Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First Course vs Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC Second Course: deaths from any cause. Trial comparisons, record NCT03284424-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03284424-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.610.5330.682wilson
Risk in group 20.3330.06150.792wilson
Risk difference, group 1 minus group 20.277-0.1890.558newcombe hybrid score
Risk ratio, group 1 over group 21.830.3689.11log
Odds ratio, group 1 over group 23.130.27835.2log
Number needed to harm, for one more death from any cause 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
3.61from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Recurrent or Metastatic Cutaneous and Locally Advanced Unresectable cSCC First CourseParticipants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).97159EG000
Group 2Recurrent 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.
13EG001

Harm

What it counts
Total, all-cause mortality
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

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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