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Colostomy-free survival
Definition Time from randomisation to colostomy
formation (in ITT population)
Pros
•
Easy to define
•
Not affected by crossover or subsequent
treatment (eg checkpoint inhibitors)
Cons
•
? Measure of direct benefit
•
Initial colostomy can be reversed but often not
reversed
•
Colostomy can be formed both for recurrence
and late effects
Censor
bias – if imbalanced withdrawal of patients who are
censored prior to colostomy