TriangleNCT03268954 · OUTCOME
Event-Free Survival (EFS)
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 acute myeloid leukemia, or death due to any cause: up to approximately 42 months
What was measured
EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization \[WHO\] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS 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 | 15.7 | Not reported | 14.42 | 19.68 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 17.7 | Not reported | 13.63 | 20.24 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.757
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.238
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,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
- IPSS-R indicates the Revised International Prognostic Scoring System.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.557
- param Type
- Hazard Ratio (HR)
- param Value
- 0.968
- statistical Comment
- P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.757
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.238
- estimate Comment
- HR:unadjusted stratified Cox proportional hazard regression with stratification(low-blast AML,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
- IPSS-R indicates the Revised International Prognostic Scoring System.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.557
- param Type
- Hazard Ratio (HR)
- param Value
- 0.968
- statistical Comment
- P-value comparing EFS between treatment groups was based on the 1-sided Cui-Hung-Wang weighted unstratified log-rank test.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.42
- upper Limit
- 19.68
- value
- 15.7
- group Id
- OG001
- lower Limit
- 13.63
- upper Limit
- 20.24
- value
- 17.7
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 227
- units
- Participants
- description
- EFS was defined as the time from randomization to the date of an EFS event. An EFS event was defined as death or transformation to acute myelogenous leukemia (AML) (World Health Organization \[WHO\] classification as a participant having greater than 20 % blasts in the blood or marrow and an increase of blast count by 50%), whichever event occurred first, in participants with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemias (CMML). An EFS 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 acute myeloid leukemia, or death due to any cause: up to approximately 42 months
- title
- Event-Free Survival (EFS)
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice