what is the difference between serious and fulfillexpeditecriteria ?
fulfillexpeditecriteria is not in the docs.
2
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Documentation about fulfillexpeditedcriteria will be added to open.fda.gov soon. See github.com/FDA/open.fda.gov/issues/66 – Adam Jul 24 '14 at 18:40
1
For
seriousvalues mappings, see this similar SE question: Seriousness values on OpenFDA. The short answer is (quoting Sean Herron):1 = The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomali, or other serious condition.
2 = The adverse event did not result in any of the above.
For
fulfillexpeditecriteriaand other variables you may come across, I suggest referencing the PDF both Sean and I mentioned in the linked SE question: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/UCM350390.pdf . That document is not specific to OpenFDA but instead the source system upstream from the API OpenFDA exposes. The short answer is (quoting the PDF):Value is 1 (1=yes) for identified expedited reports (15-day); 2 for all others.
EDIT: You can see more information on the fields at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM149932.pdf as well. For example, the following for fulfillexpeditedcriteria:
Does this case fulfill the local criteria for an expedited report?
Be sure to remember that different countries might have different standards
