TriangleNCT02610777 · 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 date of randomization until transformation to AML, or death due to any cause (up to approximately 5 years)
What was measured
EFS is defined as the time from the date of randomization to the date of the occurrence of an event. An event is defined as death or transformation to AML for HR MDS/CMML participants, whichever occurs first, or defined as death for low-blast AML participants. HR MDS/CMML participants without documented EFS event will be censored at the date of the last response assessment. HR MDS/CMML participants with no response assessment and no death will be censored at the date of randomization. Low-blast AML participants without documentation of death will be censored at the date the participant was last known to be alive. HR MDS/CMML participants who received alternative antineoplastic therapy before death or transformation to AML will be censored at the date of last adequate assessment prior to starting alternate antineoplastic therapy. The Kaplan-Meier estimate was used for the analysis.
Analysis population: ITT Population was defined as all participants who were randomized.
Groups in this outcome
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 62 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 17.6 | Not reported | 11.96 | 20.50 | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 21.0 | Not reported | 17.41 | 28.02 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.469
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.061
- 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
- Event-Free Survival (EFS)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.092
- p Value Comment
- P-value comparing EFS between treatment groups was based on the unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.706
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.469
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.061
- 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
- Event-Free Survival (EFS)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.092
- p Value Comment
- P-value comparing EFS between treatment groups was based on the unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.706
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.96
- upper Limit
- 20.50
- value
- 17.6
- group Id
- OG001
- lower Limit
- 17.41
- upper Limit
- 28.02
- value
- 21.0
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- EFS is defined as the time from the date of randomization to the date of the occurrence of an event. An event is defined as death or transformation to AML for HR MDS/CMML participants, whichever occurs first, or defined as death for low-blast AML participants. HR MDS/CMML participants without documented EFS event will be censored at the date of the last response assessment. HR MDS/CMML participants with no response assessment and no death will be censored at the date of randomization. Low-blast AML participants without documentation of death will be censored at the date the participant was last known to be alive. HR MDS/CMML participants who received alternative antineoplastic therapy before death or transformation to AML will be censored at the date of last adequate assessment prior to starting alternate antineoplastic therapy. The Kaplan-Meier estimate was used for the analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG001
- title
- Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
- param Type
- MEDIAN
- population Description
- ITT Population was defined as all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From date of randomization until transformation to AML, or death due to any cause (up to approximately 5 years)
- title
- Event-Free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice