TriangleNCT01658878 · OUTCOME
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 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)
What was measured
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. Abbreviations: ALT = Alanine Aminotransferase; AST = Aspartate Aminotransferase; ULN = Upper Limit of Normal.
Analysis population: All treated participants
Groups in this outcome
Cohort 1 Uninfected HCC: Treatment 1
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.1 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 2
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 3
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 4
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 3 mg/kg every 2 weeks
Cohort 1 Uninfected HCC: Treatment 5
Dose Escalation: Uninfected hepatocellular carcinoma (HCC) participants received nivolumab 10 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 6
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 7
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 HCV Infected: Treatment 8
Dose Escalation: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 9
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.1 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 10
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 0.3 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 11
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 1 mg/kg every 2 weeks
Cohort 1 HBV Infected: Treatment 12
Dose Escalation: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib naive/intolerant received nivolumab 3 mg/kg every 2 weeks
Cohort 2 Uninfected Sorafenib Progressors: Treatment 2
Dose Expansion: Uninfected hepatocellular carcinoma (HCC) participants who are sorafenib progressors received nivolumab 3 mg/kg every 2 weeks
Cohort 2 HCV Infected: Treatment 3
Dose Expansion: Hepatitis C (HCV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 2 HBV Infected: Treatment 4
Dose Expansion: Hepatitis B (HBV)-infected participants received nivolumab 3 mg/kg every 2 weeks
Cohort 3: Treatment 1
Arm A: Advance hepatocellular carcinoma (HCC) participants received nivolumab 240 mg every 2 weeks
Cohort 3: Treatment 2
Arm B: Advance hepatocellular carcinoma (HCC) participants received Sorafenib 400 mg twice a day
Cohort 4: Treatment 1
Arm A: Participants received nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks
Cohort 4: Treatment 2
Arm B: Participants received nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks
Cohort 4: Treatment 3
Arm C: Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks
Cohort 5: Treatment 1
Participants received nivolumab 240 mg every 2 weeks
Cohort 6: Treatment 1
Participants received nivolumab 240 mg every 2 weeks + cabozantinib 40 mg once daily
Cohort 6: Treatment 2
Participants received nivolumab 3 mg/kg every 2 weeks + ipilimumab 1 mg/kg every 6 weeks + cabozantinib 40 mg once daily
| Group | Source count |
|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 1 |
| Cohort 1 Uninfected HCC: Treatment 2 | 3 |
| Cohort 1 Uninfected HCC: Treatment 3 | 3 |
| Cohort 1 Uninfected HCC: Treatment 4 | 3 |
| Cohort 1 Uninfected HCC: Treatment 5 | 13 |
| Cohort 1 HCV Infected: Treatment 6 | 3 |
| Cohort 1 HCV Infected: Treatment 7 | 4 |
| Cohort 1 HCV Infected: Treatment 8 | 3 |
| Cohort 1 HBV Infected: Treatment 9 | 5 |
| Cohort 1 HBV Infected: Treatment 10 | 3 |
| Cohort 1 HBV Infected: Treatment 11 | 3 |
| Cohort 1 HBV Infected: Treatment 12 | 4 |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 56 |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 57 |
| Cohort 2 HCV Infected: Treatment 3 | 48 |
| Cohort 2 HBV Infected: Treatment 4 | 51 |
| Cohort 3: Treatment 1 | 59 |
| Cohort 3: Treatment 2 | 60 |
| Cohort 4: Treatment 1 | 47 |
| Cohort 4: Treatment 2 | 49 |
| Cohort 4: Treatment 3 | 45 |
| Cohort 5: Treatment 1 | 47 |
| Cohort 6: Treatment 1 | 35 |
| Cohort 6: Treatment 2 | 34 |
Reported measurements
ALT or AST > 3 X Upper limit of Normal (ULN)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 22 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 32 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 29 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 25 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 27 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 21 | Not reported | Not reported | Not reported | Not reported |
Alanine Transaminase (ALT) OR AST > 5 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 22 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 22 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 19 | Not reported | Not reported | Not reported | Not reported |
ALT or Aspartate Transaminase (AST) > 10 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 9 | Not reported | Not reported | Not reported | Not reported |
ALT or AST > 15 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
ALT or AST > 20 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 2 | Not reported | Not reported | Not reported | Not reported |
Total Bilirubin > 2 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 8 | Not reported | Not reported | Not reported | Not reported |
Total Bilirubin > 8 X ULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Total Bilirubin >8XULN if Elevated at Entry Or >5XULN if Normal at Entry
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Concurrent ALT OR AST Elevation > 3 X ULN with Total Bilirubin > 2 X ULN within One Day
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
Concurrent ALT or AST elevation > 3 X ULN with Total Bilirubin > 2 X ULN within 30 Days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
Concurrent Alt>=10XULN & Total Bilirubin >=2XULN Or 2X Baseline if Elevated Total Bilirubin at Entry
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Uninfected HCC: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 Uninfected HCC: Treatment 5 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 7 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 9 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 10 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 11 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HBV Infected: Treatment 12 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 2
- title
- ALT or AST > 3 X Upper limit of Normal (ULN)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 1
- title
- Alanine Transaminase (ALT) OR AST > 5 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 1
- title
- ALT or Aspartate Transaminase (AST) > 10 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 1
- title
- ALT or AST > 15 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 0
- title
- ALT or AST > 20 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- Total Bilirubin > 2 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Total Bilirubin > 8 X ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Total Bilirubin >8XULN if Elevated at Entry Or >5XULN if Normal at Entry
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- Concurrent ALT OR AST Elevation > 3 X ULN with Total Bilirubin > 2 X ULN within One Day
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 1
- title
- Concurrent ALT or AST elevation > 3 X ULN with Total Bilirubin > 2 X ULN within 30 Days
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- Concurrent Alt>=10XULN & Total Bilirubin >=2XULN Or 2X Baseline if Elevated Total Bilirubin at Entry
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 13
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 3
- group Id
- OG011
- value
- 4
- 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. Abbreviations: 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- 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
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice