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CTCAE GRADING

Which CTCAE versions does Burna AI support?

CTCAE v5.0 and CTCAE v6.0, both live on one engine. The trial decides which version applies, an operator can choose a version for a particular run, and every graded event records the version that produced it, so a monitor or sponsor can re-derive the grade later. NCI published CTCAE v5.0 on November 27, 2017 (837 terms, MedDRA 20.1) and CTCAE v6.0 on July 22, 2025 (850 terms, MedDRA 28.0); both cover 26 organ system classes. Between them, 790 terms keep their name, 7 are renamed (Platelet count decreased became Thrombocytopenia), 45 are new in v6.0 and 40 exist only in v5.0, and cut-offs moved for terms such as Neutrophil count decreased. Every change, term by term, is at ctcae.ai/v6-changes.

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