TriangleNCT02654132 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to date of progression or death (up to approximately 21 months)
What was measured
PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
Analysis population: All randomized participants
Groups in this outcome
E-Pd Cohort
Elotuzumab + Pomalidomide + Dexamethasone
Pd Cohort
Pomalidomide + Dexamethasone
| Group | Source count |
|---|---|
| E-Pd Cohort | 60 |
| Pd Cohort | 57 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| E-Pd Cohort | 10.25 | Not reported | 6.54 | NA | Upper limit not reached |
| Pd Cohort | 4.70 | Not reported | 2.83 | 7.62 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0043
- param Type
- Hazard Ratio (HR)
- param Value
- 0.51
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0043
- param Type
- Hazard Ratio (HR)
- param Value
- 0.51
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit not reached
- group Id
- OG000
- lower Limit
- 6.54
- upper Limit
- NA
- value
- 10.25
- group Id
- OG001
- lower Limit
- 2.83
- upper Limit
- 7.62
- value
- 4.70
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 57
- units
- Participants
- description
- PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1\. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Elotuzumab + Pomalidomide + Dexamethasone
- id
- OG000
- title
- E-Pd Cohort
- description
- Pomalidomide + Dexamethasone
- id
- OG001
- title
- Pd Cohort
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to date of progression or death (up to approximately 21 months)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice