{"analyses":[{"ciLowerLimit":"1.047","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.095","estimateComment":"Strata adjusted odds ratio by the logistic regression method. Stratified by 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":"0.0265","paramType":"Odds Ratio (OR)","paramValue":"1.48","statisticalComment":"Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \\>T2N0), PDL1 status(high vs low/negative)","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"469"},{"groupId":"OG001","value":"441"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"530"}],"units":"Participants"}],"description":"The proportion of patients who undergo cystectomy is defined as the proportion patients who undergo radical cystectomy after the neoadjuvant treatment. The denominator will be patients in the FAS.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"The full analysis set (FAS) Intention to treat included all randomized patients.","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Proportion of Patients Who Undergo Cystectomy","type":"SECONDARY","unitOfMeasure":"Participants"}