{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.59","value":"53.3"},{"groupId":"OG001","spread":"9.31","value":"52.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"329"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.25","value":"1.0"},{"groupId":"OG001","spread":"8.35","value":"1.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"109"}],"units":"Participants"}],"title":"Change at Day 1 of Cycle 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"332"},{"groupId":"OG001","value":"329"}],"units":"Participants"}],"description":"NCCN-FACT FBlSI-18 is an 18-item participant completed questionnaire, designed to assess impact of cancer therapy on urothelial cancer-related symptoms and quality of life based on numerical point scoring of symptoms/concerns. It included four subscales: Disease related symptoms- physical subscale with 9 items, disease related symptoms- emotional subscale with 2 items, treatment side effects subscale with 5 items and general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging from 0=not at all to 4=very much. Items that were negatively framed, and the scores were reversed for analysis so that higher scores= good quality of life. Overall score: total of 18 items, ranging from 0=severely symptomatic to 72=asymptomatic. Higher scores= better functioning or lower symptom burden.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.","id":"OG000","title":"Avelumab + Best Supportive Care (BSC)"},{"description":"As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.","id":"OG001","title":"Best Supportive Care"}],"paramType":"MEAN","populationDescription":"The full analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants who had data available for this outcome measure and 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.","reportingStatus":"POSTED","timeFrame":"Baseline, Day 1 of Cycle 6 (1 cycle=28 days)","title":"Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6","type":"SECONDARY","unitOfMeasure":"units on a scale"}