{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}]}],"title":"Any treatment-emergent AEs (TEAEs)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"86"}]}],"title":"Treatment-related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"62"}]}],"title":"Any grade 3-5 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"49"}]}],"title":"Treatment-related grade 3-5 TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"35"}]}],"title":"Any serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"15"}]}],"title":"Treatment-related serious TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"}]}],"title":"Any TEAEs leading to treatment discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}]}],"title":"Treatment-related TEAEs leading to treatment discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"title":"Any TEAEs leading to death"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}],"title":"Treatment-related TEAEs leading to death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"AE=untoward medical occurrence associated with use of study intervention, whether or not considered related. Treatment emergent adverse event (TEAE)=newly occurring/worsening AE after first dose of study treatment, within 30 days after last dose. According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: Grade(G)3=severe AE, G4=life-threatening, urgent intervention indicated, G5=death related to AE. Participants who discontinued treatment due to treatment related TEAEs captured under TEAEs leading to treatment discontinuation. SAE=event at any dose led to death;life-threatening;required inpatient hospitalization/prolongation of existing hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect/ important medical event. Treatment related AEs, SAEs, deaths also included. Treatment relatedness was judged by investigator.","groups":[{"description":"Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.","id":"OG000","title":"Enfortumab Vedotin - Cohort 1"},{"description":"Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.","id":"OG001","title":"Enfortumab Vedotin - Cohort 2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set: includes all participants who received at least one dose of enfortumab vedotin.","reportingStatus":"POSTED","timeFrame":"Cohort 1: median treatment duration time: 4.60 months (range 0.5, 43.0); Cohort 2: median treatment duration time: 5.98 months (range 0.3 to 25.8)","title":"Number of Participants With Adverse Events (AEs): Final Analysis","type":"SECONDARY","unitOfMeasure":"Participants"}