TriangleNCT02807454 · OUTCOME
Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm
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 enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
What was measured
Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
Analysis population: All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.
Groups in this outcome
Simon Stage 1: D2 Arm
Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles
Simon Stage 1: D2 + Pomalidomide + Dexamethasone
Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles
| Group | Source count |
|---|---|
| Simon Stage 1: D2 Arm | 32 |
| Simon Stage 1: D2 + Pomalidomide + Dexamethasone | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Simon Stage 1: D2 Arm | 5.74 | Not reported | 2.0 | 6.5 | Not reported |
| Simon Stage 1: D2 + Pomalidomide + Dexamethasone | 8.05 | Not reported | 3.7 | 12.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 6.5
- value
- 5.74
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 12.9
- value
- 8.05
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Progression-free survival was calculated as the time between the enrollment to the first documentation of progressive disease or death from any cause during study, whichever occurs earlier using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles
- id
- OG000
- title
- Simon Stage 1: D2 Arm
- description
- Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles
- id
- OG001
- title
- Simon Stage 1: D2 + Pomalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose of the study medications. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.
- reporting Status
- POSTED
- time Frame
- From enrollment to first documentation of progressive disease or death from any cause during study, whichever occurs earlier (up to approximately 66 months)
- title
- Kaplan-Meier Estimate of Progression-Free Survival (PFS) - Simon Stage 1: D2 Arm
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice