{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"45"},{"groupId":"OG002","value":"146"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"19"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"34"}]}],"title":"NCI-CTCAE Grade 3/4/5 TEAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"107"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"157"}],"units":"Participants"}],"description":"The type, incidence, relatedness and severity of treatment emergent adverse events of ADSTILADRIN as assessed by NCI-CTCAE V4.03 were monitored.","groups":[{"description":"Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease","id":"OG000","title":"Carcinoma in Situ"},{"description":"Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)","id":"OG001","title":"Papillary Disease"},{"description":"All patients","id":"OG002","title":"Total"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set","reportingStatus":"POSTED","timeFrame":"60 Months","title":"Safety of ADSTILADRIN","type":"SECONDARY","unitOfMeasure":"Participants"}