{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"2"}]}],"title":"TSH > ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"2"}]}],"title":"TSH > ULN WITH TSH <= ULN AT BASELINE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"0"}]}],"title":"TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"0"}]}],"title":"TSH > ULN WITH FT3/FT4 TEST MISSING"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"5"}]}],"title":"TSH < LLN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"4"}]}],"title":"TSH < LLN WITH TSH >= LLN AT BASELINE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"}]}],"title":"TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"2"}]}],"title":"TSH < LLN WITH FT3/FT4 TEST MISSING"}],"denoms":[{"counts":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"18"}],"units":"Participants"}],"description":"Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* TSH value \\> ULN and\n* with baseline TSH value \\<= ULN\n* with at least one FT3/FT4 test value \\< LLN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\>= LLN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test.\n* TSH \\< LLN and\n* with baseline TSH value \\>= LLN\n* with at least one FT3/FT4 test value \\> ULN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\<= ULN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test","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 TSH measurement","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 Thyroid Tests","type":"SECONDARY","unitOfMeasure":"Participants"}