Outcomes
toxicities, death
RECURRENCE, RECURRENCE, DISEASE
The primary endpoint was recurrence-free survival, defined as the time from randomisation to the first radiological evidence of recurrence or death from any cause (whichever occurred first); patients without recurrence were censored at the date of the last follow-up visit. Recurrence was defined as the appearance of a new lesion confirmed by imaging. Disease recurrence was evaluated with the use of contrast-enhanced CT or MRI at baseline and every 12 weeks from the date of randomisation. Secondary endpoints were overall survival, effects of plasma mitotane concentration on patient outcome, efficacy of mitotane in predefined subgroups of patients, measures of quality of life, and toxicities. Overall survival was measured from the date of randomisation to the date of death from any cause, and the data were censored at the date of the last follow-up visit. Details on how plasma mitotane concentrations were assessed are given in the Both recurrence-free survival and overall survival in ADIUVO Observational were measured from the date of registration in the study.Safety measures used in the study included physical examination and clinical laboratory tests (haematology, blood chemistries, and creatinine clearance).