{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"0.77","value":"0.58"}]}],"title":"Observed"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"0.7","value":"0.5"}]}],"title":"Predicted"}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"A comparative assessment of PK will be performed between Observed and Predicted adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study. The observed PK metrics were calculated using non-compartmental analysis (NCA), the predicted PK metrics were derived based on the adolescent population pharmacokinetics (popPK) model.","dispersionType":"Full Range","groups":[{"description":"All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) and 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":"OG000","title":"GEP-NET and PPGL"}],"paramType":"MEDIAN","populationDescription":"The PK Analysis Set (PKAS) consisted of all participants who had at least one valid (i.e., not flagged for exclusion) PK measurement. Original NETTER-P protocol intended to conduct separate analyses for the GEP-NET and the PPGL populations. However, the protocol was amended to allow combined analyses for PK across the two patient indications.","reportingStatus":"POSTED","timeFrame":"Up to 72 hours after the first Lutetium [Lu 177] dotatate dose","title":"Pharmacokinetics (PK) Parameter: Tmax - Based on Blood Radioactivity Concentration Data","type":"SECONDARY","unitOfMeasure":"hr"}