TriangleNCT02917941 · OUTCOME
Time to Progression (TTP)
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
- Up to approximately 33 months
What was measured
TTP was measured as the time in months from the first dose of study treatment to the date of the first documented PD as assessed using IMWG criteria. PD required one of the following: increase of ≥ 25% from nadir in: serum M-component (absolute increase ≥ 0.5 g/dL); urine M-component (absolute increase ≥ 200 mg/24 hours); in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase \> 10 mg/dL); development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) attributed solely to plasma cell proliferative disease.
Analysis population: FAS included all participants who received at least one dose of study drug during the treatment period.
Groups in this outcome
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
| Group | Source count |
|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 22.57 | Not reported | 17.51 | NA | Upper limit of CI was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of CI was not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 17.51
- upper Limit
- NA
- value
- 22.57
- denoms
- counts
- group Id
- OG000
- value
- 34
- units
- Participants
- description
- TTP was measured as the time in months from the first dose of study treatment to the date of the first documented PD as assessed using IMWG criteria. PD required one of the following: increase of ≥ 25% from nadir in: serum M-component (absolute increase ≥ 0.5 g/dL); urine M-component (absolute increase ≥ 200 mg/24 hours); in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase \> 10 mg/dL); development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium \> 11.5 mg/dL) attributed solely to plasma cell proliferative disease.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
- id
- OG000
- title
- Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
- param Type
- MEDIAN
- population Description
- FAS included all participants who received at least one dose of study drug during the treatment period.
- reporting Status
- POSTED
- time Frame
- Up to approximately 33 months
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice