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    Composite Endpoint

    Single endpoint combining multiple component outcomes (e.g., MACE = death + MI + stroke).

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Composite endpoints increase event rates and statistical power but require careful component selection, individually adjudicated definitions, and reporting of component breakdowns to avoid overstating treatment effect.

    What this means in practice

    Standard practice in cardiovascular device trials (MACE, MALE, NACE); FDA reviewers focus on whether benefit is consistent across components.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2NIH·1
    1. 1
      FDA Composite Endpoints Guidance
      Verified
      FDAfda.gov
    2. 2
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov
    3. 3
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov

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