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Description

Clinical cancer trial investigators are required to submit Hypersensitivity Events (HEs) as a part of their adverse event reporting to ClinicalTrials.gov. Data collection approaches and choice of controlled terminology to code these events vary, impacting the study of HE events on a population level. We analyzed trial data over 18 years and found a lack of granularity when coding the severity of events, as well as a lack of consistent notation of the etiologic agent.

Learning Objective: After viewing this poster presentation, the learner will be able to identify issues challenges to representation of hypersensitivity events in cancer clinical trials and describe the implications this has on population-level analysis and other data sharing efforts.

Authors:

Christina Eldredge (Presenter)
University of South Florida

James Andrews, University of South Florida
Maryam Zolnoori, Mayo Clinic
Timothy Patrick, University of Wisconsin-Milwaukee
Joel Gallagher, Allergy and Asthma Center of North Carolina
Cesar Lam, Moffitt Cancer Center
Jake Luo, University of Wisconsin-Milwaukee

Presentation Materials:

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