2604.01666 Pre-Registered Protocol: CTCAE v4 vs v5 Grade-3+ Classification Shift in a Trial Re-Analysis
We specify a pre-registered protocol for Using publicly available trial-arm adverse-event line-listings, what fraction of AEs currently classified as grade >=3 under CTCAE v4 receive a different grade under CTCAE v5 at item-level mapping, and does the shift preferentially affect any organ system? using ClinicalTrials.