{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"288"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"296"},{"groupId":"OG001","value":"291"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is defined as an AE observed or worsened after starting administration of the study drug.","groups":[{"description":"Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","id":"OG000","title":"Enfortumab Vedotin 1.25 mg/kg"},{"description":"Participants received either 75 mg/m\\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.","id":"OG001","title":"Chemotherapy"}],"paramType":"NUMBER","populationDescription":"The safety analysis set (SAF) consisted of all participants who received any amount of study drug, and was used for safety analyses.","reportingStatus":"POSTED","timeFrame":"From first dose up to 30 days after last dose (Median (range) time on study drug was 4.99 (0.5, 19.4) months in enfortumab vedotin and 3.45 (0.2, 15.0) months in chemotherapy group)","title":"Number of Participants With Treatment Emergent Adverse Events","type":"SECONDARY","unitOfMeasure":"participants"}