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The need to identify adverse events related to COVID-19 is hampered by the fact that COVID-19 is a new disease for which current versions of the Medical Dictionary for Regulatory Activities (MedDRA) do not have specific codes. The following information is available from the MedDRA Maintenance and Support Services Organization (MSSO):

There may also be a desire to identify more conditions than COVID-19 (e.g., COVID-19 pneumonia). 

Modification of AE forms for ongoing trials may be difficult. An alternative can be to instruct sites on using key text (e.g., "COVID-19") in the verbatim description of the event (AETERM). Programs can then be written to derive an NSV to indicate the relationship of the adverse event to COVID-19.

Example

This example shows 2 adverse events related to COVID-19 in a subject in an ongoing study. Note that most required and expected fields have been omitted from this example. This example was prepared using a version of MedDRA that does not include specific terms for COVID-19.

 ae.xpt

ae.xpt

Row

STUDYID

DOMAIN

USUBJID

AESEQ

AETERM

AELLT

AEDECOD

AESTDTC

AEENDTC

AESTDY

AEENDY


AEEPRELI
1COV-4AE2001COVID-19Coronavirus infectionCorona virus infection2020-03-312020-04-262349
Y
2COV-4AE2002COVID-19 pneumoniaPneumonia viralPneumonia viral2020-04-052020-04-262849
Y

AE NSV Metadata

Example

This example shows 2 adverse events related to COVID-19 in a subject in an ongoing study. Note that most required and expected fields have been omitted from this example. This example was prepared using the updated version 23.0 of MedDRA that includes specific terms for COVID-19.

 ae.xpt

ae.xpt

Row

STUDYID

DOMAIN

USUBJID

AESEQ

AETERM

AELLT

AEDECOD

AESTDTC

AEENDTC

AESTDY

AEENDY


AEEPRELI
1COV-4AE2001COVID-19COVID-19COVID-192020-03-312020-04-262349
Y
2COV-4AE2002COVID-19 pneumoniaPneumonia viralPneumonia viral2020-04-052020-04-262849
Y

AE NSV Metadata

An emergency release of MedDRA that included COVID-19 terms was posted, using the same version number (23.0) as the previous version. The version used for a submission can be clarified in the Define-XML document.

Reference NameExternal DictionaryDictionary Version
MedDRA (external)MedDRA23 - with COVID 19 terms

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9 Comments

  1. Would it be better for AECOV19 to contain 'relationship' values? i.e. Related/Not-Related? I'm thinking of a context where AEs are collected and sites are asked if the event is related to COVID or not. I would think someone's COVID-19 diagnosis would be collected as its own record in MH or CE/AE, so categorizing someone in to a group of 'SUBJECTS DIAGNOSED WITH COVID-19' should be feasible using those records? 

    We are asking sites to categorize hospitalizations and deaths as 'COVID-related' or not on our CRFs, so might be good to standardize a NSV for that information under the EVENTS class. 


    1. The NSV given is intended to allow identification of subjects who have COVID-19, given that current coding via MedDRA does not include a specific term for COVID-19.

      Is it necessary to identify, for subjects who have COVID-19, which of their AEs are related to COVID-19.  Signs and symptoms of a disease are generally not recorded as separate AEs, so what AEs would need to be identified as related to COVID-19?  Complications of COVID-19?

      1. The example was changed and now includes an NSV for relationship to COVID-19.

  2. I too find the value "SUBJECT DIAGNOSED WITH COVID-19" a little awkward in this example. Depending on the trial design and study population, it could be a given that the subject has been diagnoses with COVID-19.  To me also it seems to be a COV19 relationship type question, so RELATED or NON-RELATED would be more appropriate.  Alternatively using Y or N as flags might work equally well. 

    1. This example is in the section for ongoing studies, rather than studies for the prevention or treatment of COVID-19, so subjects would not be assumed to have COVID-19.

  3. I agree with David Parkinsonand Justin Ritz a COVID-19 related NSV would be more practical.  One of the assumptions we are currently making is that analyses would be required to show all AEs and Aes not related to COVID-19

    1. The example was changed and now includes an NSV for relationship to COVID-19.

  4. Regarding the new MedDRA COVID-19 terms, and using these in ongoing studies to identify COVID-19 events - the user guide could be more explicit about the reasons for not attempting to incorporate the new term into older versions of MedDRA. i.e. explicitly state why this causes problems. This is an instance of the general problem about what to do when a study has an event term dictionary made from MedDRA augmented with additional terms that are needed by the study, but which aren't included in MedDRA.



    1. Advice about use of terms not in MedDRA is the purview of the MSSO.  The example above is based on information in the cited materials from the MSSO.