TriangleNCT02181413 · OUTCOME
Correlation Between MRD Status and 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 up to 107 months
What was measured
PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure.
Analysis population: ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed indicates the number of participants available for analysis in the specified category.
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 | 214 |
| Ixazomib Citrate | 342 |
Reported measurements
MRD- at Study Entry
| Group | Source count |
|---|---|
| Placebo | 75 |
| Ixazomib Citrate | 117 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 32.5 | Not reported | 19.32 | NA | Upper limit of 95% CI was not estimable due to censoring. |
| Ixazomib Citrate | 38.6 | Not reported | 33.81 | NA | Upper limit of 95% CI was not estimable due to censoring. |
MRD+ at Study Entry
| Group | Source count |
|---|---|
| Placebo | 139 |
| Ixazomib Citrate | 225 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 18.5 | Not reported | 15.70 | 21.91 | Not reported |
| Ixazomib Citrate | 23.1 | Not reported | 20.24 | 25.69 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.386
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.969
- 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 Description
- MRD- at Study Entry
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.034
- 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
- 0.612
- statistical Method
- Log Rank
- ci Lower Limit
- 0.539
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.920
- 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 Description
- MRD+ at Study Entry
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.010
- 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
- 0.704
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.386
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.969
- 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 Description
- MRD- at Study Entry
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.034
- 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
- 0.612
- statistical Method
- Log Rank
- ci Lower Limit
- 0.539
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.920
- 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 Description
- MRD+ at Study Entry
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.010
- 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
- 0.704
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of 95% CI was not estimable due to censoring.
- group Id
- OG000
- lower Limit
- 19.32
- upper Limit
- NA
- value
- 32.5
- comment
- Upper limit of 95% CI was not estimable due to censoring.
- group Id
- OG001
- lower Limit
- 33.81
- upper Limit
- NA
- value
- 38.6
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 117
- units
- Participants
- title
- MRD- at Study Entry
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.70
- upper Limit
- 21.91
- value
- 18.5
- group Id
- OG001
- lower Limit
- 20.24
- upper Limit
- 25.69
- value
- 23.1
- denoms
- counts
- group Id
- OG000
- value
- 139
- group Id
- OG001
- value
- 225
- units
- Participants
- title
- MRD+ at Study Entry
- denoms
- counts
- group Id
- OG000
- value
- 214
- group Id
- OG001
- value
- 342
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the date of first documentation of PD as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 107 months in this outcome measure.
- 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. Overall number analyzed is the number of participants with data available for analyses. Number analyzed indicates the number of participants available for analysis in the specified category.
- reporting Status
- POSTED
- time Frame
- From randomization up to 107 months
- title
- Correlation Between MRD Status and Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice