{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"180"},{"groupId":"OG002","value":"173"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"72"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"51"}]}],"title":"Treatment emergent SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"182"},{"groupId":"OG002","value":"177"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.","groups":[{"description":"Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.","id":"OG000","title":"Avelumab"},{"description":"Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.","id":"OG001","title":"Avelumab + PLD"},{"description":"PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.","id":"OG002","title":"Pegylated Liposomal Doxorubicin (PLD)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.","reportingStatus":"POSTED","timeFrame":"From the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months); based on cutoff date: 13 July 2022.","title":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}