MedDRA coding, produced by the same engine that grades CTCAE.
Coding happens inside grading, as one workflow. Every adverse event Burna grades carries its MedDRA v28.0 LLT code, with the source sentence attached and the CTCAE criterion alongside.
E2B(R3) · case output
Argus · Veeva · ArisGlobal
encoded record · ENC-2031
Anemia
meddra v28.0 · coded in the same pass
source sentence · attached
“Hemoglobin 7.4 g/dL on day 8; transfusion given.”
the coder no longer reads the same note twice
Coding happens inside grading, as one workflow.
The line your clinician wrote
CTCAE v6.0
MedDRA lowest level term
“8 to 9 loose stools daily”
Diarrhea · Grade 3
Diarrhoea
“ANC 800 cells/mm³”
Neutrophil count decreased · Grade 3
Neutrophil count decreased
“ALT 3.5 x upper limit of normal”
Alanine aminotransferase increased · Grade 2
Alanine aminotransferase increased
Every CTCAE term carries its MedDRA lowest level term, so the grade and the code come out of the same reading of the same sentence and agree by construction.
Illustrative rendering. US and international spellings both resolve to the same term, which is why the first row reads two ways.
One pass over the note produces both codes.
MedDRA is the vocabulary regulators speak. CTCAE is the vocabulary clinicians speak. Both must travel with every graded adverse event in clinical research. Burna produces them together because they describe the same clinical fact and the cost of producing them separately, by separate teams, in separate workflows, is the line item every safety budget knows by heart.
Terms arrive MedDRA-coded, LLT to SOC, because extraction is structured from the start.
The signature is captured on the encoded record, with the CTCAE grade and the MedDRA LLT code together. One artifact serves both audiences.