Oncologic secondary criteria
TgAb
RECURRENCES, DISEASE, METAB, REMISSION, METASTASES

Thyroglobulin levels after surgery alone (ultrasentive thyroglobuliin, usTg/T4) measured while on T4 treatment, 8 +/−2 weeks postoperatively, before stimulation or administration of radioactive iodinePercent of patients in complete remission (excellent response) at 3 and 5 years after randomization, as defined by negative imaging and either unstimultaed ultrasensitive thyroglobulin while on L-thyroxine treatment (usTg/LT4) ≤ 0.2 ng/mL) without anti-Tg antibodies (TgAb) or TSH-stimulated Tg<1ng/mLThe endpoint of 5 years reflects the data from a prospective multicenter study of 715 patients [Brassard M et al J Clin Endocrinol Metab 2011] reporting that 81% of recurrences occurred within 5 years, and from a retrospective study of 1020 patients followed for 10 years [Durante C et al J Clin Endocrinol Metab 2013] reporting that all structural recurrences occurred within 8 years, with 77% occurring within 5 years.Percent of patients at 1, 3, and 5 years after randomization with structural incomplete response in the neck defined by the presence of structural or functional evidence of disease, with any Tg level, with or without anti-Tg antibodiesPercent of patients at 1, 3, and 5 years after randomization with biological incomplete response defined by negative imaging and suppressed Tg ≥1 ng/mL or stimulated Tg≥10ng/mL or rising anti-Tg antibody levelsPercent of patients at 1, 3, and 5 years after randomization with an indeterminate response defined by nonspecific findings on imaging studies and/or faint uptake in thyroid bed on RAI scanning (if performed) and/or on stimulated Tg detectable but <1ng/mL and/or stable or declining TgAb in the absence of structural or functional diseasePercent of patients at 1, 3, and 5 years after randomization with diagnosis of distant metastases on metabolic imaging (Percent of patients at 1, 3, and 5 years after randomization having undergone further treatment (surgery or 2nd therapeutic administration of 131I, number of retreatments per patient and indication for each retreatment)