TriangleNCT02181413 · OUTCOME
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
- Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 months)
What was measured
PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was 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 free light chain (FLC) levels must be \>10 milligrams per deciliter (mg/dL); participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.
Analysis population: Intent-to-Treat (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 | 21.3 | Not reported | 17.97 | 24.67 | Not reported |
| Ixazomib Citrate | 26.5 | Not reported | 23.69 | 33.81 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.582
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.890
- estimate Comment
- HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.720
- statistical Comment
- P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.582
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.890
- estimate Comment
- HR was based on Cox's proportional hazard regression model stratified by pre-induction regimen, pre-induction ISS stage and response after transplantation. \<1 HR indicates better prevention of progression in Ixazomib arm compared to Placebo.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.720
- statistical Comment
- P-value was based on log-rank test stratified by pre-induction regimen, International Staging System (ISS) stage and response after transplantation.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.97
- upper Limit
- 24.67
- value
- 21.3
- group Id
- OG001
- lower Limit
- 23.69
- upper Limit
- 33.81
- value
- 26.5
- denoms
- counts
- group Id
- OG000
- value
- 261
- group Id
- OG001
- value
- 395
- units
- Participants
- description
- PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was 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 free light chain (FLC) levels must be \>10 milligrams per deciliter (mg/dL); participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.
- 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
- Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data.
- reporting Status
- POSTED
- time Frame
- Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks (up to 45 months)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice