{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityComment":"Other","nonInferiorityType":"EQUIVALENCE","pValue":"0.016","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.4","upperLimit":"3.9","value":"2.6"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.4","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"The PFS by PD-L1 status in UC cohort is reported. The PFS estimates are adjusted for baseline eastern cooperative oncology (ECOG), smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.","id":"OG000","title":"Expansion UC PD-L1 High Cohort"},{"description":"Participants with UC (PD-L1 status low/Negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.","id":"OG001","title":"Expansion UC PD-L1 Low/Negative Cohort"}],"paramType":"MEDIAN","populationDescription":"The UC cohort participants with PD-L1 status as high (\\>= 25% tumor cell membrane or \\>=25% immune cell staining) and low/negative (\\<25% tumor cell membrane and \\<25% immune cell staining) included in the As-treated population were analyzed. As-treated population included all participants who received any dose of study drug. The \"Number of participants Analyzed\" denotes the number of participants evaluated for this outcome measure.","reportingStatus":"POSTED","timeFrame":"From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)","title":"Adjusted Comparison of PFS by PD-L1 Status in UC Cohort in the Dose-expansion Phase","type":"SECONDARY","unitOfMeasure":"Months"}