{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Safety in adolescents with SSTR-positive GEP-NETs and PPGLs as a pooled cohort was evaluated through the incidence of AEs and laboratory abnormalities after the first 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":"during first cycle of Lutetium [Lu 177] dotatate treatment (Cycle = 56 days)","title":"Incidence of Adverse Events (AEs) and Lab Toxicities After 1st Lutathera Administration","type":"PRIMARY","unitOfMeasure":"Participants"}