{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Non-CR/Non-PD"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Not Evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"}],"units":"Participants"}],"description":"Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.","groups":[{"description":"Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.","id":"OG000","title":"Secondary Expansion Cohort: Urothelial Carcinoma"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.","reportingStatus":"POSTED","timeFrame":"Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931","title":"Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee","type":"SECONDARY","unitOfMeasure":"Participants"}