I don't see the need to rename. Surely any clinical event that may befall a patient - og any procedure - would by definition be ADVERSE .. i.e. to the detriment of the patient??

I am not in favour of renaming the table AE into CEP. I'd rather not collect Adverse Events and medical procedures in the same table.

Let's keep in line with the current practice of many cohorts in EuroCOORD and collect in the tblAE only (serious) adverse events defined as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment".

Medical or diagnostical procedures do not belong in the AE table as these procedures are planned. Undesirable or harmful effects, such as infection, hemorrhage, inflammation, scarring, loss of function, or changes in local blood due to(surgical) procedure can be registred in the AE table but not the procedure itsself.

Thus, transfer medical procedures like END, FIBS, LIVB, ANG, CERC to a new table and keep the table AE for adverse events only, using the here above ICH-GCP definition for adverse events.
I think it keeps things more simple and it is more logical from a data manager point of view.

Monique

I am not in favour of renaming the table AE into CEP. I'd rather not collect Adverse Events and medical procedures in the same table.

Let's keep in line with the current practice of many cohorts in EuroCOORD and collect in the tblAE only (serious) adverse events defined as "Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment".

Medical or diagnostical procedures do not belong in the AE table as these procedures are planned. Undesirable or harmful effects, such as infection, hemorrhage, inflammation, scarring, loss of function, or changes in local blood due to(surgical) procedure can be registred in the AE table but not the procedure itsself.

Thus, transfer medical procedures like END, FIBS, LIVB, ANG, CERC to a new table and keep the table AE for adverse events only, using the here above ICH-GCP definition for adverse events.
I think it keeps things more simple and it is more logical from a data manager point of view.

Monique

Ok, lets summarize your proposed changes (not regarding the name of tblAE):

Remove HG (HG - Hodgkins Lymphoma) from tblDIS
Change the description of NADM-CERV to contain "grade 2 or higher" (http://www.hicdep.org/wik.../TableAe/FieldAeSpec FieldAeSpec)
Regarding Cancer reporting: There is currently a group working on it. So I suggest we wait on the results.

Add severe infections to tblDIS
Remove ANG,BYP,END from AE_ID coding (strangely, there is already a code under AE_SPEC ICP...). As they are basically duplicates now, I think we should definitely remove them.

Any comments? I would suggest waiting on the cancer related changes and add the other changes.

Cheers Lukas