{"analyses":[{"ciLowerLimit":"0.556","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.863","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0005","pValueComment":"One-sided log-rank test was used.","paramType":"Hazard Ratio (HR)","paramValue":"0.69","statisticalComment":"Analysis was performed using a Cox's Proportional Hazard model.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.9","upperLimit":"26.1","value":"21.4"},{"groupId":"OG001","lowerLimit":"12.9","upperLimit":"17.9","value":"14.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"350"}],"units":"Participants"}],"description":"Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.","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 to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}