Procedures
Cancer
ADVERSE EVENT, CANCER
Mitotane (Lysodren) was provided by HRA Pharma (Paris, France) and was administered orally starting at latest 7 days after randomisation. The mitotane dose was adjusted by the local investigator with the target of reaching and maintaining plasma mitotane concentrations of 14–20 mg/L because these concentrations have been associated with therapeutic efficacy.Assessments were scheduled at baseline and every 12 weeks for 2 years, both in the ADIUVO trial and the ADIUVO Observational study, and included history, physical examination, imaging, standard biochemical measurements, and hormone work-up. After 2 years, the follow-up intervals were decided by the local investigators and was done with visits every 3–4 months in both studies. Safety was assessed with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0).