Outcomes
DFS, tumor, death
RECURRENCE, TUMOR, RECURRENCE
The two primary endpoints were DFS among all randomized patients (ITT population) and DFS among patients with a tumor PD-L1 expression level of 1% or more. DFS was defined as the time from randomization to the date of first recurrence (local recurrence within the urothelial tract, local recurrence outside the urothelial tract or distant recurrence) or death (from any cause), whichever occurred first. Recurrence was assessed by the investigators. The study protocol encouraged biopsy if feasible and deemed appropriate by the investigator.Secondary endpoints included non-urothelial tract recurrence-free survival (NUTRFS), OS and disease-specific survival in both trial populations. NUTRFS was defined as the time from randomization to the date of first documented recurrence (local non-urothelial tract or distant) or death (from any cause), whichever occurred first.Exploratory endpoints included safety, side effects, distant metastasis-free survival and QOL. QOL was assessed using the EORTC QLQ-C30 (