TriangleNCT01592370 · OUTCOME
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
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
- approximately up to 4 years
Analysis population: All treated participants in the nivo dara cohort
Groups in this outcome
Nivolumab + Daratumumab_Cohort A1
ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects \> 75 years old
Nivolumab + Daratumumab_Cohort A2
ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
Nivolumab + Daratumumab_Cohort B1
ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
Nivolumab + Daratumumab_Cohort B2
D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
| Group | Source count |
|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 6 |
| Nivolumab + Daratumumab_Cohort A2 | 5 |
| Nivolumab + Daratumumab_Cohort B1 | 41 |
| Nivolumab + Daratumumab_Cohort B2 | 22 |
Reported measurements
ALT or AST >3xULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
ALT or AST >5xULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
ALT or AST >10xULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
ALT or AST >20xULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
Total Bilirubin > 2xULN
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
ALT or AST >3xULN with total Bilirubin >2xULN within 30 days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- ALT or AST >3xULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- ALT or AST >5xULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- ALT or AST >10xULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- ALT or AST >20xULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- Total Bilirubin > 2xULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- ALT or AST >3xULN with total Bilirubin >2xULN within 30 days
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 22
- units
- Participants
- groups
- description
- ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects \> 75 years old
- id
- OG000
- title
- Nivolumab + Daratumumab_Cohort A1
- description
- ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
- id
- OG001
- title
- Nivolumab + Daratumumab_Cohort A2
- description
- ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
- id
- OG002
- title
- Nivolumab + Daratumumab_Cohort B1
- description
- D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
- id
- OG003
- title
- Nivolumab + Daratumumab_Cohort B2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants in the nivo dara cohort
- reporting Status
- POSTED
- time Frame
- approximately up to 4 years
- title
- Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice