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Firstly, several verbatim terms had been left uncoded into ADECS.
Nearly all the verbatim terms simply mapped onto coding terms in MedDRA.
From the narratives it could be discerned that verbatim terms were coded to identical terms.
In the meantime, verbatim terms reported by the patient can be reported directly, or grouped together into recognised symptom PTs.
All of our coding from the verbatim terms in the appendix D of the CSR was done blind, as was coding from the case report forms.
The verbatim terms and the ADECS coding terms were transcribed first into these sheets, allowing all coding to be done before the drug names were added in.
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And if you prefer the old way — which let you specify certain terms to look for verbatim while still leaving others open to Google's search logic — you can accomplish the same thing by wrapping each verbatim term in quotes, "like this".
AEs were listed by subject, including verbatim term, coded MedDRA term, severity, and relationship to treatment.
When a verbatim term was reported, one researcher (EM) consulted the medical coding dictionary used in the study and chose the closest matching lowest level term, and then the preferred term that was used in summary tables.
These listings provided data on individual adverse events experienced by each patient in the trial and included the verbatim term, severity of the event, if the adverse event was serious or led to discontinuation of the study drug, and whether the adverse event was considered to be related to the study drug (see table 3).
Dr. Henriksson, a professor of history at Shepherd College in West Virginia, is the compiler of "Non Campus Mentis" (Workman Publishing), which is a history of the world taken verbatim from term papers and exams at American and Canadian colleges.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com