{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"67"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"}],"units":"Participants"}],"description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Cohort 1 - (urothelial progressive disease) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.\n\nCohort 2 (Bone-only) Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.\n\nCohort 3 (Rare histologies) Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.","id":"OG000","title":"All Participants"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"We did not group the adverse events by cohort because we did not expect the cohorts to experience different adverse events as they were all getting the same medication at the same dose. And 68/69 participants were analyzed because one participant was enrolled and deemed ineligible prior to treatment.","reportingStatus":"POSTED","timeFrame":"Median follow-up was 61.2 months","title":"Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution","type":"SECONDARY","unitOfMeasure":"Participants"}