TriangleNCT05556616 · OUTCOME
Groups 2 and 3: Event-free Survival (EFS)
This outcome was registered, but no numerical results were posted in the captured record.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 16.7 months
What was measured
EFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; 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 plasma cell proliferative disorder.
Groups in this outcome
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denom Units Selected
- Participants
- description
- EFS was defined as the time from the date on which the first dose of study drug is administered to the date of the first documentation of an event that may include confirmed PD, discontinuation of a treatment for an AE (related or not related), or death due to any cause, whichever occurs first. PD was determined by IMWG criteria. PD: increase of \>=25 % from lowest response value in any one or more of the following: serum M-component increase \>=0.5 g/dL or urine M-component increase \>=200 mg/24-hour; difference between involved and uninvolved FLC levels increase must be \> 10 mg/dL; bone marrow plasma cell \>=10%; 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 plasma cell proliferative disorder.
- reporting Status
- NOT_POSTED
- time Frame
- Up to 16.7 months
- title
- Groups 2 and 3: Event-free Survival (EFS)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice