TriangleNCT02610777 · OUTCOME
Duration of Complete Remission (CR) in Low-blast AML
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From date of randomization until CR (up to approximately 5 years)
What was measured
Disease responses for low-blast AML is based on revised IWG response criteria for AML. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and plt of \>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all criteria for CR except for residual neutropenia (\<1.0\*10\^9/L)/TTP (\<100\*10\^9/L).
Analysis population: REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for responders with low blast AML having complete remission.
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 | 4 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 10.2 | Not reported | 0.2 | 10.2 | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 12.6 | Not reported | 5.6 | 44.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.057
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.109
- estimate Comment
- Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.383
- p Value Comment
- P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.420
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.057
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.109
- estimate Comment
- Hazard ratio was based on an unstratified Cox proportional hazard regression model and treatment as a factor in the model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.383
- p Value Comment
- P-value comparing duration of CR in low blast AML between treatment groups is based on unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.420
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 10.2
- value
- 10.2
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 44.0
- value
- 12.6
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Disease responses for low-blast AML is based on revised IWG response criteria for AML. CR for low-blast AML: morphologic leukemia-free state, ANC of more than 1.0\*10\^9/L and plt of \>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia. CR with incomplete blood count recovery for low-blast AML: some participants fulfill all criteria for CR except for residual neutropenia (\<1.0\*10\^9/L)/TTP (\<100\*10\^9/L).
- dispersion Type
- Full Range
- 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
- REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment. Data is reported for responders with low blast AML having complete remission.
- reporting Status
- POSTED
- time Frame
- From date of randomization until CR (up to approximately 5 years)
- title
- Duration of Complete Remission (CR) in Low-blast AML
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice