{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.90","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":"0.0021","paramType":"Hazard Ratio (HR)","paramValue":"0.75","statisticalComment":"P-value is based on a chi-squared test with one degree of freedom.","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.6","upperLimit":"71.7","value":"67.8"},{"groupId":"OG001","lowerLimit":"55.4","upperLimit":"64","value":"59.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"530"}],"units":"Participants"}],"description":"EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"The full analysis set (FAS) Intention to treat included all randomized patients","reportingStatus":"POSTED","timeFrame":"Up to 24 months","title":"Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}