TriangleNCT01564537 · OUTCOME
Overall Response Rate in Participants Defined by Polymorphism
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
What was measured
Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal.
Analysis population: ITT population included all randomized participants. Overall number analyzed is the number of participants available with data.
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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to (up to approximately 41 months).
| Group | Source count |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 117 |
| Placebo + Lenalidomide + Dexamethasone | 115 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 80.3 | Not reported | 72.0 | 87.1 | Not reported |
| Placebo + Lenalidomide + Dexamethasone | 75.7 | Not reported | 66.8 | 83.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.45
- estimate Comment
- Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.332
- p Value Comment
- P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).
- param Type
- Odds Ratio (OR)
- param Value
- 1.30
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.69
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.45
- estimate Comment
- Odds ratio is from logistic regression model with prognostic factors: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve),and ISS Stage at Screening (I or II, III). Odds ratio \> 1 favors Ixazomib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.332
- p Value Comment
- P-value is from Cochran-Mantel-Haenszel stratified by: prior therapies (1, 2 or 3), proteasome inhibitor (exposed, naïve), and ISS Stage at Screening (I or II, III).
- param Type
- Odds Ratio (OR)
- param Value
- 1.30
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 72.0
- upper Limit
- 87.1
- value
- 80.3
- group Id
- OG001
- lower Limit
- 66.8
- upper Limit
- 83.2
- value
- 75.7
- denoms
- counts
- group Id
- OG000
- value
- 117
- group Id
- OG001
- value
- 115
- units
- Participants
- description
- Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal.
- 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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (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 progressive disease (PD) or unacceptable toxicity, whichever occurred first up to (up to approximately 41 months).
- id
- OG001
- title
- Placebo + Lenalidomide + Dexamethasone
- param Type
- NUMBER
- population Description
- ITT population included all randomized participants. Overall number analyzed is the number of participants available with data.
- reporting Status
- POSTED
- time Frame
- Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
- title
- Overall Response Rate in Participants Defined by Polymorphism
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice