TriangleNCT03268954 · OUTCOME
Event-Free 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 transformation to AML if eligible or death (up to approximately 42 months)
What was measured
Event was defined as death or transformation to AML in participants with MDS or CMML, whichever occurred first. Transformation to AML was defined, according to World Health Organization (WHO) Classification as a participant having \>20% blasts in the blood or marrow and increase of blast count by 50%. Event was defined as death in participants with low-blast AML.
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 | 8.44 | 14.32 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 14.6 | Not reported | 9.99 | 18.99 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.608
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.263
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.
- group Description
- Event-Free 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
- =0.240
- p Value Comment
- P-value comparing EFS 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
- 0.877
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.608
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.263
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification factors (IPSS-R risk groups=very high,high,or intermediate for HRMDS/CMML),treatment as factor.HR\<1:better prevention of EFS in combination arm than azacitidine arm.
- group Description
- Event-Free 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
- =0.240
- p Value Comment
- P-value comparing EFS 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
- 0.877
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.44
- upper Limit
- 14.32
- value
- 12.8
- group Id
- OG001
- lower Limit
- 9.99
- upper Limit
- 18.99
- value
- 14.6
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 227
- units
- Participants
- description
- Event was defined as death or transformation to AML in participants with MDS or CMML, whichever occurred first. Transformation to AML was defined, according to World Health Organization (WHO) Classification as a participant having \>20% blasts in the blood or marrow and increase of blast count by 50%. Event was defined as death in participants with low-blast AML.
- 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 transformation to AML if eligible or death (up to approximately 42 months)
- title
- Event-Free 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