TriangleNCT01658878 · OUTCOME
Number of Participants With Laboratory Abnormalities in Specific Thyroid 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
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. Abbreviations: FT3 = Free T3; FT4 = Free T4; LLN = Lower Limit of Normal; ULN = Upper Limit of Normal; TSH = Thyroid Stimulating Hormone
Analysis population: All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.
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 | 56 |
| Cohort 2 HCV Infected: Treatment 3 | 47 |
| Cohort 2 HBV Infected: Treatment 4 | 50 |
| Cohort 3: Treatment 1 | 54 |
| Cohort 3: Treatment 2 | 57 |
| Cohort 4: Treatment 1 | 41 |
| Cohort 4: Treatment 2 | 38 |
| Cohort 4: Treatment 3 | 42 |
| Cohort 5: Treatment 1 | 41 |
| Cohort 6: Treatment 1 | 35 |
| Cohort 6: Treatment 2 | 32 |
Reported measurements
TSH > ULN (Upper Limit of Normal)
| 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 1 | 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 | 3 | 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 | 1 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 19 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 23 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 21 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 17 | Not reported | Not reported | Not reported | Not reported |
TSH > ULN with TSH <= ULN at baseline
| 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 1 | 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 | 1 | 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 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 17 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 18 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 20 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 14 | Not reported | Not reported | Not reported | Not reported |
TSH > ULN with at least one FT3/FT4 test value < LLN (Lower Limit of Normal)
| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 8 | 2 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Naive/Intolerant: Treatment 1 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 6 | 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 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 7 | Not reported | Not reported | Not reported | Not reported |
TSH > ULN with all other FT3/FT4 test values >= LLN
| 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 | 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 | 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 | 1 | 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 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 14 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 9 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 11 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
TSH > ULN with FT3/FT4 test missing
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 1 HCV Infected: Treatment 6 | 1 | 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 | 1 | 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 | 2 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 2 | 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 | 4 | 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 | 6 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 4 | Not reported | Not reported | Not reported | Not reported |
TSH < LLN
| 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 | 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 | 0 | 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 | 7 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HCV Infected: Treatment 3 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 HBV Infected: Treatment 4 | 9 | 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 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 16 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 13 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 10 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 9 | Not reported | Not reported | Not reported | Not reported |
TSH < LLN with TSH >= LLN at baseline
| 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 | 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 | 0 | 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 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 7 | 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 | 7 | 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 1 | 15 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 12 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 5: Treatment 1 | 5 | 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 | 9 | Not reported | Not reported | Not reported | Not reported |
TSH < LLN with at least one FT3/FT4 test value > 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 | 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 | 7 | 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 | 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 | 1 | 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 | 9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 6 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 5 | Not reported | Not reported | Not reported | Not reported |
TSH < LLN with all other FT3/FT4 test values <= 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 | 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 | 0 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 Uninfected Sorafenib Progressors: Treatment 2 | 4 | 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 | 8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3: Treatment 2 | 4 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 3 | 3 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Cohort 6: Treatment 2 | 4 | Not reported | Not reported | Not reported | Not reported |
TSH < LLN with FT3/FT4 test missing
| 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 | 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 | 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 | 2 | 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 | 1 | 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 | 0 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4: Treatment 2 | 5 | 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 | 2 | 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 | 0 | 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
- 5
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TSH > ULN (Upper Limit of Normal)
- 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
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- TSH > ULN with TSH <= ULN at baseline
- 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
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TSH > ULN with at least one FT3/FT4 test value < LLN (Lower Limit of Normal)
- 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
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- TSH > ULN with all other FT3/FT4 test values >= LLN
- 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
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- TSH > ULN with FT3/FT4 test missing
- 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
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TSH < LLN
- 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
- 2
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TSH < LLN with TSH >= LLN at baseline
- 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
- TSH < LLN with at least one FT3/FT4 test value > 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
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 1
- title
- TSH < LLN with all other FT3/FT4 test values <= 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
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- TSH < LLN with FT3/FT4 test missing
- 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
- 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. Abbreviations: 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
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.
- 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 Thyroid Tests
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice