TriangleNCT01564537 · OUTCOME
Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]
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 the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
What was measured
Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17).
Analysis population: ITT population was defined as all randomized participants. Overall number analyzed is the number of participants available for analysis.
Groups in this outcome
Ixazomib+ Lenalidomide + Dexamethasone
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
Placebo + Lenalidomide + Dexamethasone
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
| Group | Source count |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 36 |
| Placebo + Lenalidomide + Dexamethasone | 33 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 42.2 | Not reported | 27.56 | 56.74 | Not reported |
| Placebo + Lenalidomide + Dexamethasone | 29.4 | Not reported | 16.99 | 44.22 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.516
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.626
- estimate Comment
- HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.764
- param Type
- Hazard Ratio (HR)
- param Value
- 0.916
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.516
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.626
- estimate Comment
- HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.764
- param Type
- Hazard Ratio (HR)
- param Value
- 0.916
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 27.56
- upper Limit
- 56.74
- value
- 42.2
- group Id
- OG001
- lower Limit
- 16.99
- upper Limit
- 44.22
- value
- 29.4
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 33
- units
- Participants
- description
- Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
- id
- OG000
- title
- Ixazomib+ Lenalidomide + Dexamethasone
- description
- Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
- id
- OG001
- title
- Placebo + Lenalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT population was defined as all randomized participants. Overall number analyzed is the number of participants available for analysis.
- reporting Status
- POSTED
- time Frame
- From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
- title
- Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice