{"analyses":[{"ciLowerLimit":"0.554","ciNumSides":"TWO_SIDED","ciPctValue":"95.877","ciUpperLimit":"0824","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","otherAnalysisDescription":"95% CI for hazard ratio: 0.558 - 0.817","pValue":"<0.0001","pValueComment":"Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \\>T2N0), PDL1 status(high vs low/negative)","paramType":"Hazard Ratio (HR)","paramValue":"0.68","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median EFS was not reached due to insufficient number of participants with events 75th percentile EFS was not reached due to insufficient number of participants with events.","groupId":"OG000","lowerLimit":"13.4","upperLimit":"NA","value":"NA"},{"comment":"75th percentile EFS was not reached due to insufficient number of participants with events.","groupId":"OG001","lowerLimit":"8.6","upperLimit":"NA","value":"46.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"530"}],"units":"Participants"}],"description":"EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, 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) includes all randomized patients","reportingStatus":"POSTED","timeFrame":"Up to 48 months","title":"Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event","type":"PRIMARY","unitOfMeasure":"months"}