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CTCAE vocabulary and grade definitions

(Michel Van Speybroeck) #1

I’m trying to map oncology specific data sets to the CDM v5.1.0 . Adverse events in the source data are coded using CTCAE v 4.0 . These codes are part of MedDRA (at LLT level) but -in addition - CTCAE also allows a ‘grade’ to be assigned to an adverse event. From what I could see on the forum, SNOMED is mapped to MedDRA at PT level, so I have two questions:

  1. Is the most sensible approach mapping the corresponding SNOMED code at PT level in concept_id and keep the original LLT code as source value?
  2. Any suggestions for handling the grade of the AE?

(Christian Reich) #2


  1. It would be very “sensible” to do LLT-based mapping, however, it would be about 5 times the work. Can you help? :smile: Plus, according to MedDRA, LLTs are synonyms of LTs, but that seems not be true in many cases. They really are hierarchically more granular concepts.

  2. AE: Can you show us what they look like? We could add them as concepts, Currently you would put them into the Observation table. If you have to link them to the Condition you’d need a record in the FACT_RELATIONSHIP table. However, we have a current subgroup thinking about modelling Oncology. Can you come in there and bring this up there?

(Michel Van Speybroeck) #3
  1. Happy to work on the mappings from LLT codes to SNOMED if that’s advisable (and can be limited ad interim to the list of 791 codes that are part of CTCAE)

  2. Re. grades, this is how it looks like for three different CTCAE codes

I’ll take your advice on the oncology subgroup

(Christian Reich) #4


That would be wonderful.

Are these grade descriptions public, or proprietary?

Also, they appear not oncology specific. In fact, none of the examples are. Maybe it is something for the general CDM WG, rather than just the oncology one?

(Michel Van Speybroeck) #5

CTCAE codes are public. See also https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm

The codes are indeed not oncology specific : it’s a subset of the broader set of MedDRA LLT terms. The grade codes however are a specific feature of CTCAE.