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(ULN)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"1"},{"groupId":"OG008","value":"2"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"10"},{"groupId":"OG013","value":"10"},{"groupId":"OG014","value":"22"},{"groupId":"OG015","value":"5"},{"groupId":"OG016","value":"9"},{"groupId":"OG017","value":"7"},{"groupId":"OG018","value":"22"},{"groupId":"OG019","value":"14"},{"groupId":"OG020","value":"11"},{"groupId":"OG021","value":"17"},{"groupId":"OG022","value":"12"},{"groupId":"OG023","value":"19"}]}],"title":"Alanine Transaminase (ALT) OR AST > 5 X 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":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"4"},{"groupId":"OG013","value":"5"},{"groupId":"OG014","value":"10"},{"groupId":"OG015","value":"4"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"2"},{"groupId":"OG018","value":"8"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"7"},{"groupId":"OG021","value":"2"},{"groupId":"OG022","value":"5"},{"groupId":"OG023","value":"9"}]}],"title":"ALT or Aspartate Transaminase (AST) > 10 X 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":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"2"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"2"},{"groupId":"OG013","value":"3"},{"groupId":"OG014","value":"3"},{"groupId":"OG015","value":"1"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"2"},{"groupId":"OG018","value":"2"},{"groupId":"OG019","value":"3"},{"groupId":"OG020","value":"2"},{"groupId":"OG021","value":"1"},{"groupId":"OG022","value":"1"},{"groupId":"OG023","value":"3"}]}],"title":"ALT or AST > 15 X 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":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"1"},{"groupId":"OG013","value":"3"},{"groupId":"OG014","value":"2"},{"groupId":"OG015","value":"1"},{"groupId":"OG016","value":"2"},{"groupId":"OG017","value":"1"},{"groupId":"OG018","value":"2"},{"groupId":"OG019","value":"2"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"1"},{"groupId":"OG022","value":"0"},{"groupId":"OG023","value":"2"}]}],"title":"ALT or AST > 20 X ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"5"},{"groupId":"OG013","value":"9"},{"groupId":"OG014","value":"10"},{"groupId":"OG015","value":"6"},{"groupId":"OG016","value":"13"},{"groupId":"OG017","value":"12"},{"groupId":"OG018","value":"11"},{"groupId":"OG019","value":"9"},{"groupId":"OG020","value":"2"},{"groupId":"OG021","value":"17"},{"groupId":"OG022","value":"5"},{"groupId":"OG023","value":"8"}]}],"title":"Total Bilirubin > 2 X 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":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"3"},{"groupId":"OG015","value":"0"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"5"},{"groupId":"OG019","value":"4"},{"groupId":"OG020","value":"0"},{"groupId":"OG021","value":"1"},{"groupId":"OG022","value":"0"},{"groupId":"OG023","value":"1"}]}],"title":"Total Bilirubin > 8 X ULN"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"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":"0"},{"groupId":"OG013","value":"1"},{"groupId":"OG014","value":"4"},{"groupId":"OG015","value":"1"},{"groupId":"OG016","value":"3"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"5"},{"groupId":"OG019","value":"4"},{"groupId":"OG020","value":"0"},{"groupId":"OG021","value":"2"},{"groupId":"OG022","value":"0"},{"groupId":"OG023","value":"1"}]}],"title":"Total Bilirubin >8XULN if Elevated at Entry Or >5XULN if Normal at Entry"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"3"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"7"},{"groupId":"OG015","value":"5"},{"groupId":"OG016","value":"9"},{"groupId":"OG017","value":"10"},{"groupId":"OG018","value":"9"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"10"},{"groupId":"OG022","value":"4"},{"groupId":"OG023","value":"7"}]}],"title":"Concurrent ALT OR AST Elevation > 3 X ULN with Total Bilirubin > 2 X ULN within One Day"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"1"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"1"},{"groupId":"OG011","value":"1"},{"groupId":"OG012","value":"3"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"7"},{"groupId":"OG015","value":"5"},{"groupId":"OG016","value":"9"},{"groupId":"OG017","value":"11"},{"groupId":"OG018","value":"9"},{"groupId":"OG019","value":"7"},{"groupId":"OG020","value":"1"},{"groupId":"OG021","value":"11"},{"groupId":"OG022","value":"4"},{"groupId":"OG023","value":"7"}]}],"title":"Concurrent ALT or AST elevation > 3 X ULN with Total Bilirubin > 2 X ULN within 30 Days"},{"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":"1"},{"groupId":"OG013","value":"0"},{"groupId":"OG014","value":"0"},{"groupId":"OG015","value":"1"},{"groupId":"OG016","value":"2"},{"groupId":"OG017","value":"1"},{"groupId":"OG018","value":"0"},{"groupId":"OG019","value":"0"},{"groupId":"OG020","value":"0"},{"groupId":"OG021","value":"0"},{"groupId":"OG022","value":"0"},{"groupId":"OG023","value":"1"}]}],"title":"Concurrent Alt>=10XULN & Total Bilirubin >=2XULN Or 2X Baseline if Elevated Total Bilirubin at Entry"}],"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":"57"},{"groupId":"OG014","value":"48"},{"groupId":"OG015","value":"51"},{"groupId":"OG016","value":"59"},{"groupId":"OG017","value":"60"},{"groupId":"OG018","value":"47"},{"groupId":"OG019","value":"49"},{"groupId":"OG020","value":"45"},{"groupId":"OG021","value":"47"},{"groupId":"OG022","value":"35"},{"groupId":"OG023","value":"34"}],"units":"Participants"}],"description":"Participants with abnormalities in liver function tests related to potential drug-induced liver injury. Blood samples were collected and analyzed for liver function parameters, including alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Abnormalities were assessed relative to the upper limit of normal (ULN) for each parameter.\n\nAbbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.","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","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 Liver Tests","type":"PRIMARY","unitOfMeasure":"Participants"}