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Last Post 08 Sep 2013 12:00 AM by  SuperUser Account
Name of tblAE
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05 Sep 2013 12:00 AM

    Hi everybody

    In our last telephone conference, we noted that the name of tblAE may not be the best fit, as it contains not only adverse events, but also clinical procedures and non-adverse events.

    Hence we propose to rename tblAE to tblCEP (Clinical Events and Procedures). To keep the column names consistent, we would rename AE_D, AE_ID, AE_SPEC to CEP_D, CEP_ID, CEP_SPEC (and do the same to the optional fields).

    In the coding table of the field AE_ID (CEP_ID)(http://www.hicdep.org/wik...eldAeId#CodingTable) we would separate procedures from events (we identified so far: END, FIBS, LIVB, ANG, CERC).

    Any comments to this?

    Best, Lukas

    PS: The draft-release of Hicdep 1.70 is not too far away. If you have any other comments to make that should go into this release, speak out soon :)



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    05 Sep 2013 12:00 AM


    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??


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    06 Sep 2013 12:00 AM
    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


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    07 Sep 2013 12:00 AM
    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


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    Posts:289
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    08 Sep 2013 12:00 AM


    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
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