TriangleNCT03268954 · OUTCOME
Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
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 CR or PR (up to approximately 42 months)
What was measured
Time to first CR or PR is defined as the time from randomization to first documented CR or PR, whichever occurs first. Disease responses for HR MDS or CMML or low-blast AML cycle 6 are based on Modified IWG Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. For HR MDS or CMML-CR:\<=5% myeloblasts with normal maturation of all bone marrow cell lines,\>=11 g/dL Hgb,\>=100\*10\^9/L pl,\>=1.0\*10\^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts\>=50% decrease over pretreatment but still\>5%; For low-blast AML-CR: morphologic leukemia-free state,\>1.0\*10\^9/L neutrophils, pl\>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery: fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl \<100\*10\^9/L; PR: all CR hematological values but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
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.
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 | 206 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 208 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | NA | Not reported | 12.12 | NA | The median, and upper limit of 95% CI was not estimable due to low number of participants with event. |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | NA | Not reported | 24.61 | NA | The median, and upper limit of 95% CI was not estimable due to low number of participants with event. |
Source statistical analyses
- ci Lower Limit
- 0.628
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.234
- estimate Comment
- Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.
- group Description
- Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.228
- p Value Comment
- P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified 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
- 0.880
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.628
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.234
- estimate Comment
- Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.
- group Description
- Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission with Incomplete Blood Count Recovery (CRi)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.228
- p Value Comment
- P-value comparing time to first CR or PR or CRi (low-blast AML) between treatment groups was based on 1-sided stratified 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
- 0.880
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median, and upper limit of 95% CI was not estimable due to low number of participants with event.
- group Id
- OG000
- lower Limit
- 12.12
- upper Limit
- NA
- value
- NA
- comment
- The median, and upper limit of 95% CI was not estimable due to low number of participants with event.
- group Id
- OG001
- lower Limit
- 24.61
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 206
- group Id
- OG001
- value
- 208
- units
- Participants
- description
- Time to first CR or PR is defined as the time from randomization to first documented CR or PR, whichever occurs first. Disease responses for HR MDS or CMML or low-blast AML cycle 6 are based on Modified IWG Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. For HR MDS or CMML-CR:\<=5% myeloblasts with normal maturation of all bone marrow cell lines,\>=11 g/dL Hgb,\>=100\*10\^9/L pl,\>=1.0\*10\^9/L neutrophils, 0% blasts in peripheral blood; PR: all CR criteria met except bone marrow blasts\>=50% decrease over pretreatment but still\>5%; For low-blast AML-CR: morphologic leukemia-free state,\>1.0\*10\^9/L neutrophils, pl\>=100\*10\^9/L, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery: fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl \<100\*10\^9/L; PR: all CR hematological values but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.
- 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
- REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment.
- reporting Status
- POSTED
- time Frame
- From randomization until CR or PR (up to approximately 42 months)
- title
- Time to First Complete Remission (CR) or Partial Remission (PR) or Complete Remission With Incomplete Blood Count Recovery (CRi)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice