B.1 Patients who had surgery and a documented recurrence (n = 1108) were classified as events of both types at the date of recurrence.
B.2 Patients who had surgery and were found to be DF and remain DF until end of study (n = 12,126)
Vital status | Cause of Death | 1 - Recurrence status | 1 – Censor/Event Date | 2 – Death or Recurrence | 2 – Censor/Event Date | Number of patients |
---|---|---|---|---|---|---|
Alive | Not applicable | No event | AFU date | No event | AFU date | 10,714 |
Died | Non-cancer related | No event | Death or AFU date, whichever occurred first | Event | Death date | 1,184 |
Died | Cancer-related | No event* | Last DF date | Event** | Death date | 228 |
Determined by abstractor call for recurrence (DF) but does not assume until end of study due to cancer death (censor at last known DF).
Count as an event at death date for composite endpoint of death or recurrence. Better to possibly inflate the time to death or recurrence than censor these known events (death) as non-events at the last DF date. This would clearly overestimate recurrence-free survival.