{"analyses":[{"ciLowerLimit":"0.541","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.826","estimateComment":"The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \\>T2N0) and PDL1 status (high vs low/negative)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"0.67","statisticalComment":"Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \\>T2N0), PDL1 status(high vs low/negative)","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"24.2","upperLimit":"NA","value":"NA"},{"comment":"Median MFS was not reached due to insufficient number of participants with events 75th percentile MFS was not reached due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"15","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"530"}],"units":"Participants"}],"description":"MFS is defined as the time from date of randomization until the first recognition of distant metastases or death, whichever occurs first","dispersionType":"Inter-Quartile Range","groups":[{"description":"Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function","id":"OG000","title":"Durvalumab + Gemcitabine + Cisplatin"},{"description":"Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function","id":"OG001","title":"Gemcitabine + Cisplatin"}],"paramType":"MEDIAN","populationDescription":"The full analysis set (FAS) Intention to treat included all randomized patients.","reportingStatus":"POSTED","timeFrame":"Up to 48 months","title":"Metastasis-free Survival Per Investigator Assessment or Local Biopsy Review.","type":"SECONDARY","unitOfMeasure":"Months"}