Secondary Outcome for Safety Profile Comparison in Clinical Trials (CBD vs. Placebo)
CTIS2024-513951-33-00 Secondary Outcome 9 - FEvIR EvidenceVariable
Summary
This resource provides information on a secondary outcome measure (CTIS2024-513951-33-00) designed to evaluate safety differences between participants receiving CBD and those receiving placebo during clinical trials. The analysis focuses specifically on routine blood sample testing results and the Common Terminology Criteria for Adverse Events (CTCAE 5.0), with particular attention paid to the last week before End of Treatment (EOT).
Details
This data defines a secondary outcome measure used to assess changes in safety profiles among clinical trial participants. The core focus is comparing differences observed between the CBD-receiving group and the placebo group. Key metrics include laboratory testing of routine blood samples and the use of CTCAE 5.0 for documenting adverse events. A critical aspect highlighted is the comparative analysis specifically targeting the last week prior to EOT. By structuring this information as an FHIR EvidenceVariable Resource, it facilitates the interoperable sharing of complex clinical trial results across disparate electronic health record and research systems. This capability provides a robust foundation for advanced analyses, such as comparative safety evaluations, thereby enhancing the transparency and reproducibility of clinical trial findings.
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