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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