{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"}]}],"title":"Observed: Kidney (Probability (%) >29 Gy)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"}]}],"title":"Observed: Bone Marrow (Probability (%) >2 Gy)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"10"}],"units":"Participants"}],"description":"A comparative assessment of dosimetry for organs at risk specifically kidneys and bone marrow, was performed between adolescent patients with GEP-NETs and PPGLs as a pooled cohort and adult patients using the extrapolation model developed for the clinical study to confirm the probability of exceeding 29 Gy (kidneys) \\& 2 Gy (bone marrow) thresholds.","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":"NUMBER","populationDescription":"Dosimetry Analysis Set (DAS) consisted of all participants who had at least one valid dosimetry 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 dosimetry across the two patient indications. The number of patients was equal 10, since data from one patient was excluded from the dosimetry modeling analysis, due to technical issues during image acquisitions.","reportingStatus":"POSTED","timeFrame":"After 4 cycles of 7.4 GBq/200 mCi; each cycle is 8+/-1 weeks","title":"Calculated Probability of Exceeding the Kidney and Bone Marrow External Beam Radiation Therapy (EBRT) Threshold","type":"SECONDARY","unitOfMeasure":"probability"}