{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.9","upperLimit":"65.6","value":"48.6"}]}],"title":"Central Reader 1"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.4","upperLimit":"71.9","value":"54.5"}]}],"title":"Central Reader 2"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.7","upperLimit":"83.6","value":"65.2"}]}],"title":"Central Reader 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"296"}],"units":"Participants"}],"description":"This analysis included patients in the EAP where rhPSMA-7.3 (18F) imaging detected PLN metastasis. Regions where rhPSMA7.3 (18F) imaging detected no LN metastasis were not included (by definition of PPV), hence only TP and FP regions were considered. TPs were all patients with a surgical pathology confirmed positive region and without a FP region. FP patients were those patients with any rhPSMA7.3 (18F) PETpositive region with negative or no surgical pathology.","dispersionType":"95% Confidence Interval","groups":[{"description":"All patients who received rhPSMA-7.3 (18F) injection followed by a PET/CT scan and who underwent RP and PLND","id":"OG000","title":"Efficacy Analysis Population (EAP)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Conventional images within 60 days or at least 24 hours prior to rhPSMA-7.3 (18F) PET, followed by treatment within 60 days post IMP administration","title":"PPV of rhPSMA-7.3 (18F) PET for Detecting PLN Metastases Compared to Surgical Pathology on a Patient-level, in Which a FP Patient is Defined as Having at Least One FP Region (Right or Left Pelvis), Regardless of Any Coexisting TP Findings (Objective 4)","type":"SECONDARY","unitOfMeasure":"percentage"}