TriangleNCT03268954 · OUTCOME
Overall Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
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 until death (up to approximately 42 months)
What was measured
OS was calculated from date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored as of the date the participant was last known to be alive.
Analysis population: ITT Population included all participants who were randomized.
Groups in this outcome
Azacitidine 75 mg/m^2
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 227 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 227 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 12.8 | Not reported | 10.84 | 14.78 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 16.1 | Not reported | 11.40 | 20.24 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.580
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.178
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.
- group Description
- Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.145
- p Value Comment
- P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.826
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.580
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.178
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification factors(IPSS-R risk groups of very high,high,intermediate) and treatment as factor in model.HR\<1: longer survival time in combination arm than azacitidine arm.
- group Description
- Overall Survival in Participants who have TP53 Mutations, 17p Deletions, and/or are Determined to be in an Adverse Cytogenetic Risk Group
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.145
- p Value Comment
- P-value comparing OS between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.826
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.84
- upper Limit
- 14.78
- value
- 12.8
- group Id
- OG001
- lower Limit
- 11.40
- upper Limit
- 20.24
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 227
- units
- Participants
- description
- OS was calculated from date of randomization to the date of death due to any cause. Participants without documented death at the time of the analysis were censored as of the date the participant was last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
- id
- OG001
- title
- Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2
- param Type
- MEDIAN
- population Description
- ITT Population included all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From randomization until death (up to approximately 42 months)
- title
- Overall Survival in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice