{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"26"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Alanine aminotransferase increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Alanine aminotransferase increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"16"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Albumin decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Albumin decreased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Alkaline phosphatase increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Alkaline phosphatase increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Aspartate aminotransferase increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Aspartate aminotransferase increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Bilirubin increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Bilirubin increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Calcium decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Calcium decreased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Calcium increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Calcium increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"46"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Creatinine increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Creatinine increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"26"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Glucose decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Glucose decreased (grade 3-4)"},{"categories":[{"measurements":[{"comment":"Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.","groupId":"OG000","value":"NA"},{"comment":"Fasting glucose is required for CTCAE grading of hyperglycemia grade 1-2, not grade 3-4. Since fasting glucose was not required for this study, grade 1-2 (glucose-high) could not be determined. Only grade 3-4 was determined.","groupId":"OG001","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Glucose increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Glucose increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Phosphate decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Phosphate decreased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"11"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Potassium decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Potassium decreased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Potassium increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Potassium increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"28"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Sodium decreased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Sodium decreased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Sodium increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"title":"Sodium increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Urate increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Urate increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Amylase increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Amylase increased (grade 3-4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"32"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Lipase increased (all grades)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"88"}],"units":"Participants"}],"title":"Lipase increased (grade 3-4)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"89"}],"units":"Participants"}],"description":"A treatment-emergent laboratory abnormality is a value increases or decrease by 1 toxicity grade after the first study dose. Abnormalities were graded based NCI CTCAE version 4.03 - Grade 1: mild; Grade 2: moderate; Grade 3: severe or clinically significant; Grade 4: life-threatening.","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. Here 'Number Analyzed' for each laboratory parameter is based on the number of participants who received at least one dose of enfortumab vedotin and have a baseline and post-baseline laboratory value.","reportingStatus":"POSTED","timeFrame":"The median duration of treatment was 4.60 months for Cohort 1 [full range: 0.5, 29.4 months] and 5.98 months for Cohort 2 [full range: 0.3, 24.6 months]","title":"Number of Participants With Treatment-Emergent Laboratory Abnormalities (Serum Chemistry)","type":"SECONDARY","unitOfMeasure":"Participants"}