{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"76"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"104"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"163"},{"groupId":"OG001","value":"58"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"8"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"24"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"344"},{"groupId":"OG001","value":"345"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent AEs are events between first dose of study drug and up to 90 days after last dose of study drug or end of treatment (EOT) visit, that were absent before treatment or that worsened relative to pretreatment state.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who had received at least one dose of study drug on arm 'Avelumab+BSC' or completed Cycle 1 Day (C1D1) on arm 'BSC'.","reportingStatus":"POSTED","timeFrame":"For \"Avelumab + Best Supportive Care (BSC)'' group: Day1 up to 90 days after last dose of study drug; for BSC group: Day1 up to 90 days after EOT visit (for a maximum duration of up to approximately 70 months for both groups)","title":"Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03","type":"SECONDARY","unitOfMeasure":"Participants"}