TriangleNCT01441973 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)
What was measured
ORR is defined as the number of participants with stringent compete response \[SCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level \<100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to \<200 mg/24 hour
Analysis population: All treated participants
Groups in this outcome
Elotuzumab, 20 mg/kg
Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
Elotuzumab, 10 mg/kg
Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
Elotuzumab, All Dosages
All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
| Group | Source count |
|---|---|
| Elotuzumab, 20 mg/kg | 15 |
| Elotuzumab, 10 mg/kg | 16 |
| Elotuzumab, All Dosages | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Elotuzumab, 20 mg/kg | 13.3 | Not reported | 2.4 | 36.3 | Not reported |
| Elotuzumab, 10 mg/kg | 6.3 | Not reported | 0.3 | 26.4 | Not reported |
| Elotuzumab, All Dosages | 9.7 | Not reported | 2.7 | 23.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.4
- upper Limit
- 36.3
- value
- 13.3
- group Id
- OG001
- lower Limit
- 0.3
- upper Limit
- 26.4
- value
- 6.3
- group Id
- OG002
- lower Limit
- 2.7
- upper Limit
- 23.2
- value
- 9.7
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- ORR is defined as the number of participants with stringent compete response \[SCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level \<100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to \<200 mg/24 hour
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
- id
- OG000
- title
- Elotuzumab, 20 mg/kg
- description
- Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
- id
- OG001
- title
- Elotuzumab, 10 mg/kg
- description
- All participants on Elotuzumab therapy. Comprised of both the 20mg/kg and 10mg/kg arms
- id
- OG002
- title
- Elotuzumab, All Dosages
- param Type
- NUMBER
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice