Closed clarkliming closed 1 year ago
Let's follow-up in the G-lopo, and see how they are catagorized.
So, Demog, Disposition categories would come under "Across Therapeutic Area Safety" which is the overall term for the domains below: Demography Disposition Medical History Concomitant Medication Deaths AE Labs
I don't believe it is wrong, however, TLG-C could specify the domains under the 'Safety' category but we would also have to include AE and labs here for consistency.
I don't think this is the correct way to categorize these entries. demographics and dispositions are not only for safety assessment, but also for efficacy assessment.
In addition, if we really want to group demographics and disposition into safety output, why we separate ae and lab?
Please reconsider this
maybe @barnett11 can comment here
I had checked with two stats before, and both thought our current catagories were not ideal, hence they suggested to sperate them out and use Glopo as for reference.
The categories used by the standard Safety LoPO currently are below, Demography Disposition Medical History Exposure Con Med AE Deaths Laboratory Vital Signs ECG
TODO
Reorg the tlg-C by following catagories
Demography Disposition Medical History Exposure Con Med AE Deaths Laboratory Vital Signs ECG
See https://github.com/insightsengineering/tlg-catalog/issues/57#issuecomment-1628499700 for details
Original message
demographic table and disposition table should not be grouped into safety. maybe we should use another label to group them, like "study population"