{"analyses":[{"ciLowerLimit":"0.901","ciNumSides":"ONE_SIDED","ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.9130","paramType":"Cox Proportional Hazard","paramValue":"1.26","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and upper limit of 95% CI were not estimable due to the small number of events.","groupId":"OG000","lowerLimit":"13.9","upperLimit":"NA","value":"NA"},{"comment":"The upper limit of 95% CI was not estimable due to the small number of events.","groupId":"OG001","lowerLimit":"12.9","upperLimit":"NA","value":"13.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"350"}],"units":"Participants"}],"description":"NCCN-FACT FBlSI-18: 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, general function/well-being subscale with 2 items. Participants rated their level of symptoms for each item using 5-point scale ranging: 0=not at all to 4=very much. For items negatively framed, scores were reversed for analysis so that higher scores= good quality of life. DRS-P score: total 9 items, ranging from 0=severely symptomatic to 36= asymptomatic. Higher scores=better functioning or lower symptom burden. TTD: time from randomization to first time participant's score showed 3 point or greater decrease from baseline in FBlSI-DRS-P subscale for 2 consecutive assessments.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"The full analysis set included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From randomization up to the 90-Day Follow-up Visit (maximum duration of up to 41 months)","title":"Time to Deterioration (TTD) Based on National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Disease Related Symptoms-Physical Subscale (DRS-P) Scores","type":"SECONDARY","unitOfMeasure":"months"}