{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0","value":"1.098"},{"groupId":"OG001","spread":"2.8139","value":"4.022"},{"groupId":"OG002","spread":"1.6393","value":"2.280"},{"groupId":"OG003","spread":"1.2527","value":"4.110"},{"groupId":"OG004","spread":"1.3822","value":"3.007"},{"groupId":"OG005","spread":"2.5936","value":"2.608"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"11"}],"units":"Participants"}],"description":"Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose.\n\nPart 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma \\[NSCLC\\]).\n\nPart 3: Assess the safety and efficacy (sensitivity and positive predictive value \\[PPV\\] of ONM-100 for intraoperative imaging during HNSCC surgery.","dispersionType":"Standard Deviation","groups":[{"description":"All patients in this arm received a single IV administration of ONM-100) at 1 mg/kg.","id":"OG000","title":"Part 1, Cohort A"},{"description":"All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.","id":"OG001","title":"Part 1, Cohort B"},{"description":"All patients in this arm received a single IV administration of ONM-100 at 2 mg/kg.","id":"OG002","title":"Part 1, Cohort E"},{"description":"All patients in this arm received a single IV administration of ONM-100 at 3 mg/kg.","id":"OG003","title":"Part 2, Group 2"},{"description":"All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.","id":"OG004","title":"Part 2, Group 3"},{"description":"All patients in this arm received a single IV administration of ONM-100 at 1 mg/kg.","id":"OG005","title":"Part 3"}],"paramType":"MEAN","reportingStatus":"POSTED","timeFrame":"1 day","title":"Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)]","type":"PRIMARY","unitOfMeasure":"ratio"}