{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}]}],"title":"AEs during Lutathera treatment"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"title":"AEs during short-term follow-up"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Cumulative safety of Lutathera in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was assessed through the incidence of adverse events (AEs) and laboratory toxicities until 6 months after the last Lutathera dose.","groups":[{"description":"All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.","id":"OG000","title":"GEP-NET"},{"description":"All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.","id":"OG001","title":"PPGL"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Set: The Safety Set included all participants that received at least one dose of Lutathera.","reportingStatus":"POSTED","timeFrame":"From first Lutetium [Lu 177] dotatate dose to 6 months after last dose, approx. 12 months","title":"Incidence of Adverse Events (AEs) During Treatment and Short-term Follow-up","type":"SECONDARY","unitOfMeasure":"Participants"}