{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"41.5","upperLimit":"62.7","value":"52.2"},{"groupId":"OG001","lowerLimit":"7.2","upperLimit":"25.0","value":"14.5"},{"groupId":"OG002","lowerLimit":"18.5","upperLimit":"42.6","value":"29.5"},{"groupId":"OG003","lowerLimit":"17.3","upperLimit":"52.8","value":"33.3"},{"groupId":"OG004","lowerLimit":"1.3","upperLimit":"98.7","value":"50.0"}]}],"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":"28.9","upperLimit":"46.2","value":"37.2"},{"groupId":"OG001","lowerLimit":"7.1","upperLimit":"24.7","value":"14.3"},{"groupId":"OG002","lowerLimit":"18.5","upperLimit":"42.6","value":"29.5"},{"groupId":"OG003","lowerLimit":"17.3","upperLimit":"52.8","value":"33.3"},{"groupId":"OG004","lowerLimit":"1.3","upperLimit":"98.7","value":"50.0"}]}],"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":"35.1","upperLimit":"87.2","value":"64.3"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"30.8","value":"0.0"},{"groupId":"OG002","lowerLimit":"9.4","upperLimit":"99.2","value":"66.7"},{"groupId":"OG003","lowerLimit":"11.6","upperLimit":"47.8","value":"26.9"},{"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":"35.1","upperLimit":"87.2","value":"64.3"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"28.5","value":"0.0"},{"groupId":"OG002","lowerLimit":"9.4","upperLimit":"99.2","value":"66.7"},{"groupId":"OG003","lowerLimit":"11.6","upperLimit":"47.8","value":"26.9"},{"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":"12.0","upperLimit":"37.3","value":"22.9"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"22.6","value":"11.1"}]}],"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":"9.5","upperLimit":"30.4","value":"18.3"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"22.6","value":"11.1"}]}],"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":"76.5","upperLimit":"99.1","value":"92.9"},{"groupId":"OG001","lowerLimit":"28.4","upperLimit":"99.5","value":"80.0"},{"groupId":"OG002","lowerLimit":"17.0","upperLimit":"41.5","value":"28.1"},{"groupId":"OG003","lowerLimit":"19.4","upperLimit":"99.4","value":"75.0"},{"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":"35.1","upperLimit":"63.2","value":"49.1"},{"groupId":"OG001","lowerLimit":"28.4","upperLimit":"99.5","value":"80.0"},{"groupId":"OG002","lowerLimit":"17.0","upperLimit":"41.5","value":"28.1"},{"groupId":"OG003","lowerLimit":"19.4","upperLimit":"99.4","value":"75.0"},{"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 lesion level, overall, positive, and negative agreement of \\[68Ga\\]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows:\n\n* Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg\n* Positive agreement = 100% x Double positive / (Double positive + Comparator single positive)\n* Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).","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":"Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging","type":"SECONDARY","unitOfMeasure":"Percent agreement"}