This document discusses an adaptive clinical trial design that was used in a phase III oncology study. The particular adaptation was an unblinded sample size re-estimation based on interim analysis results. This required changes to the SDTM and ADaM data models to account for the interim analysis cut-off dates. The reviewer guides were also updated to explain how to identify patients in the interim analysis and which analysis datasets to use for re-calculating results based on the interim and final cut-offs.