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Suggestion for Assessment of Drug Adverse Effects using CTCAE (Common Terminology Criteria For Adverse Effects) in observation table


(Kang Mira) #1

An oncology extension to the OMOP CDM has been proposed for cancer related information and treatment. To a cancer patient, diagnosis and treatment are certainly important. Reporting Adverse Drug Reaction (ADR) is also an important part of patient care.
Since there is no suggestion on the side effect of the administered medications on the patient after receiving the diagnosis and treatment, we would like to make a proposal.

CTCAE (Common Terminology Criteria For Adverse Effects) divides severity of ADR into 5 grades from Grade 1 to 5. Each Grade is defined by its level of severity. Grade is crucial for patient care and treatment that can show the severity of ADR,

When you use MEDDRA for adverse effects, you will get information loss on severity.

Therefore, You’d better use CTCAE based OMOP vocabulary instead. In addition, the Grade from 1 to 5 should be included in qualifier values.


Please see the attached document file.

Suggestion for assessment of drug adverse effects using CTCAE (Common Terminology Criteria For Adverse Effects) in observation table.docx (1.3 MB)


(Seng Chan You) #2

I think this is really important information. How do you think, @Christian_Reich?


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