{"analyses":[{"groupDescription":"Compare tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.418","statisticalMethod":"Wilcoxon (Mann-Whitney)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.19","upperLimit":"0.69","value":"0.31"},{"groupId":"OG001","lowerLimit":"0.12","upperLimit":"0.59","value":"0.18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Tumor expression programmed death-ligand 1 (PD-L1) after combination therapy (MEDI-4736 and Tremelimumab) and after MEDI-4736 alone will be obtained by immunohistochemistry and CytoF. The unit of measure is MMI. MMI (mean metal intensity or mean mass intensity) is a signal intensity in time-of-flight mass cytometry (CyTOF), which is the same as MFI (mean fluorescent intensity) in flow cytometry. Mean metal intensity looks more common in CyTOF to tell it from the unit in mass spectrometry. Its range is from 0 to infinity.","dispersionType":"Inter-Quartile Range","groups":[{"description":"8 patients will receive an infusion of MEDI4736 (15 mg/kg intravenously, once), one to six weeks prior to surgical resection.\n\nMEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.","id":"OG000","title":"MEDI4736"},{"description":"8 patients will receive an infusion of MEDI4736 (1500 mg intravenously, once) + tremelimumab (75mg intravenously, once), one to six weeks prior to surgical resection.\n\nMEDI4736: MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.\n\nTremelimumab: Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume \\[w/v\\]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.","id":"OG001","title":"MEDI4736 + Tremelimumab"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"at a surgery within one to six weeks after treatment","title":"Tumor Expression Programmed Death-ligand 1 (PD-L1) in Patients Treated With Combination Therapy (MEDI-4736 and Tremelimumab) and in Patients Treated With MEDI-4736 Alone.","type":"SECONDARY","unitOfMeasure":"MMI (Mean Mass Intensity)"}