{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"1"}]}],"title":"ALT OR AST > 3XULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"0"}]}],"title":"ALT OR AST > 5XULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"}]}],"title":"ALT OR AST > 10XULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"ALT OR AST > 20XULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"TOTAL BILIRUBIN > 2XULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS"}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* ALT or AST \\> 3 x ULN, \\> 5 x ULN, \\> 10 x ULN and \\> 20 x ULN\n* Total bilirubin \\> 2 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN","groups":[{"description":"Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.","id":"OG000","title":"Cohort A"},{"description":"Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.","id":"OG001","title":"Cohort B"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter","reportingStatus":"POSTED","timeFrame":"From first dose to 30 days post last dose (Up to 66 months)","title":"Number of Participants With Laboratory Abnormalities in Specific Liver Tests","type":"SECONDARY","unitOfMeasure":"Participants"}