TriangleNCT02181413 · 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
- Randomization up to PD (up to 107 months)
What was measured
TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria. PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \>10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better.
Analysis population: ITT Population was defined as all participants who were randomized and had post randomization data.
Groups in this outcome
Placebo
Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
Ixazomib Citrate
Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
| Group | Source count |
|---|---|
| Placebo | 261 |
| Ixazomib Citrate | 395 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 21.4 | Not reported | 18.10 | 24.67 | Not reported |
| Ixazomib Citrate | 26.6 | Not reported | 23.69 | 33.81 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.579
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.886
- estimate Comment
- Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- p Value Comment
- P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.716
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.579
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.886
- estimate Comment
- Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- p Value Comment
- P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.716
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.10
- upper Limit
- 24.67
- value
- 21.4
- group Id
- OG001
- lower Limit
- 23.69
- upper Limit
- 33.81
- value
- 26.6
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 395
- units
- Participants
- description
- TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria. PD is defined as ≥25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be \>10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be ≥10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. Participants without documentation of PD at the time of analysis were censored at the date of last response assessment that is stable disease or better.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
- id
- OG000
- title
- Placebo
- description
- Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
- id
- OG001
- title
- Ixazomib Citrate
- param Type
- MEDIAN
- population Description
- ITT Population was defined as all participants who were randomized and had post randomization data.
- reporting Status
- POSTED
- time Frame
- Randomization up to PD (up to 107 months)
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice