{"analyses":[{"ciLowerLimit":"1.227","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.084","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0005","paramType":"Odds Ratio (OR)","paramValue":"1.60","statisticalComment":"Strata adjusted odds ratio by the logistic regression method adjusting for stratification factors: renal function , tumor stage and PDL1 status .","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"146"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"530"}],"units":"Participants"}],"description":"pCR rate is defined as the proportion of patients whose pathological staging was T0N0M0 as assessed per central pathology review using specimens obtained via radical cystectomy following the neoadjuvant treatment. The denominator for pCR will be the number of 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":"Full Analysis Set (Intention to Treat): includes all randomized subjects","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Pathologic Complete Response (pCR) Rates at Time of Cystectomy","type":"PRIMARY","unitOfMeasure":"Participants"}