{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"47.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"14.7","upperLimit":"94.7","value":"60.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"2.5","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Overall (Positive Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"47.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"47.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"14.7","upperLimit":"94.7","value":"60.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"2.5","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Overall (Overall Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.8","upperLimit":"93.2","value":"50.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"},{"groupId":"OG002","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Nodal (Positive Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.8","upperLimit":"93.2","value":"50.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"84.2","value":"0.0"},{"groupId":"OG002","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Nodal (Overall agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"Skeletal (Positive Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"Skeletal (Overall agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"Skin/Superficial (Positive Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"0.0","upperLimit":"97.5","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"title":"Skin/Superficial (Overall agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"5.3","upperLimit":"85.3","value":"40.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"2.5","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Soft Tissue/Visceral (Positive Agreement)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG001","lowerLimit":"39.8","upperLimit":"100.0","value":"100.0"},{"groupId":"OG002","lowerLimit":"5.3","upperLimit":"85.3","value":"40.0"},{"groupId":"OG003","lowerLimit":"29.2","upperLimit":"100.0","value":"100.0"},{"groupId":"OG004","lowerLimit":"2.5","upperLimit":"100.0","value":"100.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"title":"Soft Tissue/Visceral (Overall agreement)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"1"}],"units":"Participants"}],"description":"At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by \\[68Ga\\]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by \\[68Ga\\]-NeoBOMB1.","dispersionType":"95% Confidence Interval","groups":[{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG000","title":"Breast"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG001","title":"Prostate"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG002","title":"Colorectal"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG003","title":"Non-Small Cell Lung Cancer (NSCLC)"},{"description":"All eligible participants were to receive recommended dose of \\[68Ga\\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \\[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\\].","id":"OG004","title":"Small-Cell Lung Cancer (SCLC)"}],"paramType":"NUMBER","populationDescription":"Full Analysis Set (FAS).","reportingStatus":"POSTED","timeFrame":"Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1","title":"Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging","type":"SECONDARY","unitOfMeasure":"Percent agreement"}