TriangleNCT03268954 · OUTCOME
Duration of Overall Response 2 (OR2)
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
- Up to approximately 42 months
What was measured
Duration of OR2: from date of first documentation of CR+PR+HI to first documentation of PD/relapse after CR/PR for responders of CR+PR+HI for HR MDS/CMML and CR,CRi,PR for low-blast AML. For HR MDS/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, still \>5%; HI:Hgb inc \>=1.5 g/dL if baseline \<11 g/dL; pl inc\>=30\*10\^9/L if baseline\>20\*10\^9/L or inc from\<20\*10\^9/L to\>20\*10\^9/L by at least 100%; neutrophil inc by 100% and absolute inc of \>0.5\*10\^9/L if baseline \<1.0\*10\^9/L.For low-blast AML-CR: morphologic leukemia-free state,\>1.0\*10\^9 neutrophils,\>=100\*10\^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi: fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl \<100\*10\^9/L;PR:all CR hematological values but\>=50% decrease in 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. Three participants who were non-responders (for OR2) as per the IRC were included in this outcome measure as they had assessment of HI and duration of OR2 for these participants could still be derived based on the pre-specified criteria for HR MDS/CMML participants.
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 | 95 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 18.3 | Not reported | 11.17 | 30.92 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 18.9 | Not reported | 15.01 | NA | The upper limit of 95% CI was not estimable due to lower number of participants with the event. |
Source statistical analyses
- ci Lower Limit
- 0.514
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.231
- 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
- Duration of Overall Response 2 (OR2)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.151
- p Value Comment
- P-value comparing duration of overall response 2 between treatment groups was based on 1-sided 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
- 0.796
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.514
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.231
- 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
- Duration of Overall Response 2 (OR2)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.151
- p Value Comment
- P-value comparing duration of overall response 2 between treatment groups was based on 1-sided 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
- 0.796
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.17
- upper Limit
- 30.92
- value
- 18.3
- comment
- The upper limit of 95% CI was not estimable due to lower number of participants with the event.
- group Id
- OG001
- lower Limit
- 15.01
- upper Limit
- NA
- value
- 18.9
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 96
- units
- Participants
- description
- Duration of OR2: from date of first documentation of CR+PR+HI to first documentation of PD/relapse after CR/PR for responders of CR+PR+HI for HR MDS/CMML and CR,CRi,PR for low-blast AML. For HR MDS/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, still \>5%; HI:Hgb inc \>=1.5 g/dL if baseline \<11 g/dL; pl inc\>=30\*10\^9/L if baseline\>20\*10\^9/L or inc from\<20\*10\^9/L to\>20\*10\^9/L by at least 100%; neutrophil inc by 100% and absolute inc of \>0.5\*10\^9/L if baseline \<1.0\*10\^9/L.For low-blast AML-CR: morphologic leukemia-free state,\>1.0\*10\^9 neutrophils,\>=100\*10\^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia;CRi: fulfill CR criteria except residual neutropenia\<1.0\*10\^9/L or pl \<100\*10\^9/L;PR:all CR hematological values but\>=50% decrease in 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. Three participants who were non-responders (for OR2) as per the IRC were included in this outcome measure as they had assessment of HI and duration of OR2 for these participants could still be derived based on the pre-specified criteria for HR MDS/CMML participants.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Duration of Overall Response 2 (OR2)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice