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Comparison · NCT03284424-52774da0

Recurrent or Metastatic Cutaneous cSCC Cohort vs Locally Advanced Unresectable cSCC Cohort: Number of Participants Who Experienced One or More Adverse Events (AEs)

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 cSCC Cohort vs Locally Advanced Unresectable cSCC Cohort: Number of Participants Who Experienced One or More Adverse Events (AEs). Trial comparisons, record NCT03284424-52774da0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03284424-52774da0

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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 10.9710.9190.99wilson
Risk in group 20.9440.8490.981wilson
Risk difference, group 1 minus group 20.027-0.03660.124newcombe hybrid score
Risk ratio, group 1 over group 21.030.9571.11log
Odds ratio, group 1 over group 220.3910.3log
Number needed to treat, for one more participant with the outcome on Recurrent or Metastatic Cutaneous cSCC Cohort than on Locally Advanced Unresectable cSCC Cohort37.1from 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 cSCC CohortParticipants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).102105OG000
Group 2Locally Advanced Unresectable cSCC CohortParticipants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 doses (approximately 24 months).5154OG001

Outcome

Type
SECONDARY
Title
Number of Participants Who Experienced One or More Adverse Events (AEs)
Description
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who experienced an AE is presented.
Time frame
Up to approximately 56 months
Population
The analysis population consisted of all participants who received ≥1 dose of study treatment.

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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