TriangleNCT02610777 · OUTCOME
Time to AML Transformation in HR MDS or CMML Participants
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 (up to approximately 5 years)
What was measured
Time to AML transformation in HR MDS and CMML participants is defined as time from randomization to documented AML transformation. Participants without documented AML transformation at the time of the analysis are censored at the date of the last assessment. Participants who died before progression to AML are censored at the date of death. Transformation to AML is 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%.
Analysis population: ITT Population was defined as all participants who were randomized. Overall number of participants analyzed is the number of participants with data available for analyses.
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 | 43 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | NA | Not reported | NA | NA | The median and 95% confidence interval (CI) was not estimable as participants were censored. |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | NA | Not reported | NA | NA | The median and 95% CI was not estimable as the participants were censored. |
Source statistical analyses
- ci Lower Limit
- 0.200
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.579
- estimate Comment
- Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.267
- p Value Comment
- P-value is from an unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.562
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.200
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.579
- estimate Comment
- Hazard ratio (HR) is based on an unstratified Cox proportional hazard regression model with treatment as a factor.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.267
- p Value Comment
- P-value is from an unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.562
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median and 95% confidence interval (CI) was not estimable as participants were censored.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and 95% CI was not estimable as the participants were censored.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Time to AML transformation in HR MDS and CMML participants is defined as time from randomization to documented AML transformation. Participants without documented AML transformation at the time of the analysis are censored at the date of the last assessment. Participants who died before progression to AML are censored at the date of death. Transformation to AML is 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%.
- 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. Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- From date of randomization until transformation to AML (up to approximately 5 years)
- title
- Time to AML Transformation in HR MDS or CMML Participants
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice