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Normal)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"15"},{"groupId":"OG013","value":"17"},{"groupId":"OG014","value":"13"},{"groupId":"OG015","value":"11"},{"groupId":"OG016","value":"11"},{"groupId":"OG017","value":"15"},{"groupId":"OG018","value":"18"},{"groupId":"OG019","value":"11"},{"groupId":"OG020","value":"9"},{"groupId":"OG021","value":"5"},{"groupId":"OG022","value":"20"},{"groupId":"OG023","value":"14"}]}],"title":"TSH > ULN with TSH <= ULN at baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"7"},{"groupId":"OG013","value":"14"},{"groupId":"OG014","value":"6"},{"groupId":"OG015","value":"5"},{"groupId":"OG016","value":"6"},{"groupId":"OG017","value":"6"},{"groupId":"OG018","value":"10"},{"groupId":"OG019","value":"8"},{"groupId":"OG020","value":"4"},{"groupId":"OG021","value":"3"},{"groupId":"OG022","value":"6"},{"groupId":"OG023","value":"7"}]}],"title":"TSH > ULN with at least one FT3/FT4 test value < LLN (Lower Limit of Normal)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"1"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"11"},{"groupId":"OG013","value":"8"},{"groupId":"OG014","value":"14"},{"groupId":"OG015","value":"10"},{"groupId":"OG016","value":"6"},{"groupId":"OG017","value":"9"},{"groupId":"OG018","value":"11"},{"groupId":"OG019","value":"4"},{"groupId":"OG020","value":"5"},{"groupId":"OG021","value":"3"},{"groupId":"OG022","value":"11"},{"groupId":"OG023","value":"6"}]}],"title":"TSH > ULN with all other FT3/FT4 test values >= LLN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"1"},{"groupId":"OG014","value":"1"},{"groupId":"OG015","value":"2"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"4"},{"groupId":"OG018","value":"2"},{"groupId":"OG019","value":"3"},{"groupId":"OG020","value":"6"},{"groupId":"OG021","value":"0"},{"groupId":"OG022","value":"4"},{"groupId":"OG023","value":"4"}]}],"title":"TSH > ULN with FT3/FT4 test missing"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"7"},{"groupId":"OG014","value":"8"},{"groupId":"OG015","value":"9"},{"groupId":"OG016","value":"2"},{"groupId":"OG017","value":"6"},{"groupId":"OG018","value":"16"},{"groupId":"OG019","value":"13"},{"groupId":"OG020","value":"10"},{"groupId":"OG021","value":"5"},{"groupId":"OG022","value":"6"},{"groupId":"OG023","value":"9"}]}],"title":"TSH < LLN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"7"},{"groupId":"OG014","value":"7"},{"groupId":"OG015","value":"7"},{"groupId":"OG016","value":"2"},{"groupId":"OG017","value":"4"},{"groupId":"OG018","value":"15"},{"groupId":"OG019","value":"12"},{"groupId":"OG020","value":"9"},{"groupId":"OG021","value":"5"},{"groupId":"OG022","value":"4"},{"groupId":"OG023","value":"9"}]}],"title":"TSH < LLN with TSH >= LLN at baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"7"},{"groupId":"OG013","value":"3"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"1"},{"groupId":"OG016","value":"1"},{"groupId":"OG017","value":"2"},{"groupId":"OG018","value":"9"},{"groupId":"OG019","value":"6"},{"groupId":"OG020","value":"6"},{"groupId":"OG021","value":"2"},{"groupId":"OG022","value":"2"},{"groupId":"OG023","value":"5"}]}],"title":"TSH < LLN with at least one FT3/FT4 test value > ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"4"},{"groupId":"OG014","value":"3"},{"groupId":"OG015","value":"8"},{"groupId":"OG016","value":"1"},{"groupId":"OG017","value":"4"},{"groupId":"OG018","value":"5"},{"groupId":"OG019","value":"2"},{"groupId":"OG020","value":"3"},{"groupId":"OG021","value":"1"},{"groupId":"OG022","value":"3"},{"groupId":"OG023","value":"4"}]}],"title":"TSH < LLN with all other FT3/FT4 test values <= ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"1"},{"groupId":"OG015","value":"0"},{"groupId":"OG016","value":"0"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"2"},{"groupId":"OG019","value":"5"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"2"},{"groupId":"OG022","value":"1"},{"groupId":"OG023","value":"0"}]}],"title":"TSH < LLN with FT3/FT4 test missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"4"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"5"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"56"},{"groupId":"OG013","value":"56"},{"groupId":"OG014","value":"47"},{"groupId":"OG015","value":"50"},{"groupId":"OG016","value":"54"},{"groupId":"OG017","value":"57"},{"groupId":"OG018","value":"41"},{"groupId":"OG019","value":"38"},{"groupId":"OG020","value":"42"},{"groupId":"OG021","value":"41"},{"groupId":"OG022","value":"35"},{"groupId":"OG023","value":"32"}],"units":"Participants"}],"description":"Number of participants with thyroid-related laboratory abnormalities during the study. Blood samples were collected and analyzed for thyroid function markers (FT3, FT4). Abnormalities were assessed against LLN and ULN for each parameter.\n\nAbbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone","groups":[{"description":"Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks","id":"OG000","title":"Cohort 1 Uninfected HCC: Treatment 1"},{"description":"Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks","id":"OG001","title":"Cohort 1 Uninfected HCC: Treatment 2"},{"description":"Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks","id":"OG002","title":"Cohort 1 Uninfected HCC: Treatment 3"},{"description":"Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks","id":"OG003","title":"Cohort 1 Uninfected HCC: Treatment 4"},{"description":"Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks","id":"OG004","title":"Cohort 1 Uninfected HCC: Treatment 5"},{"description":"Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks","id":"OG005","title":"Cohort 1 HCV Infected: Treatment 6"},{"description":"Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks","id":"OG006","title":"Cohort 1 HCV Infected: Treatment 7"},{"description":"Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks","id":"OG007","title":"Cohort 1 HCV Infected: Treatment 8"},{"description":"Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks","id":"OG008","title":"Cohort 1 HBV Infected: Treatment 9"},{"description":"Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks","id":"OG009","title":"Cohort 1 HBV Infected: Treatment 10"},{"description":"Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks","id":"OG010","title":"Cohort 1 HBV Infected: Treatment 11"},{"description":"Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks","id":"OG011","title":"Cohort 1 HBV Infected: Treatment 12"},{"description":"Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks","id":"OG012","title":"Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1"},{"description":"Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks","id":"OG013","title":"Cohort 2 Uninfected Sorafenib Progressors: Treatment 2"},{"description":"Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks","id":"OG014","title":"Cohort 2 HCV Infected: Treatment 3"},{"description":"Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks","id":"OG015","title":"Cohort 2 HBV Infected: Treatment 4"},{"description":"Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks","id":"OG016","title":"Cohort 3: Treatment 1"},{"description":"Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day","id":"OG017","title":"Cohort 3: Treatment 2"},{"description":"Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks","id":"OG018","title":"Cohort 4: Treatment 1"},{"description":"Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks","id":"OG019","title":"Cohort 4: Treatment 2"},{"description":"Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks","id":"OG020","title":"Cohort 4: Treatment 3"},{"description":"Participants received nivolumab 240 mg every 2 weeks","id":"OG021","title":"Cohort 5: Treatment 1"},{"description":"Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily","id":"OG022","title":"Cohort 6: Treatment 1"},{"description":"Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily","id":"OG023","title":"Cohort 6: Treatment 2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.","reportingStatus":"POSTED","timeFrame":"From first dose of study medication through 100 days following last dose of study treatment (Assessed approximately 04 months up to a max of approximately 106 months)","title":"Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests","type":"PRIMARY","unitOfMeasure":"Participants"}