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The ICH E9 (R1) Estimands Guidance1 terminology does not completely addressthe conceptual needs of time-to-event estimands in the complex oncologycontext. We previously described how censoring and censoring mechanisms fortime-to-event endpoints can be embedded into the ICH E9 (R1) Estimands Guidanceterminology. This second paper by the Pharmaceutical Industry Working Group onEstimands in Oncology Censoring Mechanisms Subteam discusses special issues inthe oncology clinical context that may require different approaches than someother therapeutic areas as well as an extensions of the ICH E9 (R1) guidance.The concept of censoring is discussed in the broader context of occludingevents, with occlusion representing any loss to further follow-up and/orremoval of further collected data from analysis. Occlusion constitutes abroader concept than the estimand guidance's intercurrent event and terminalevent terminology and is appropriate to describe and handle situations likewithdrawal from assessments or situations where the requirements of differentestimands conflict. We characterize, provide additional details, practicalimplications, and examples on the application of each estimands strategy forhandling occluding events.

The Role of Occlusion: Potential Extension of the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis for Time-to-Event Oncology Studies