TriangleNCT03268954 · OUTCOME
Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence
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 RBC and platelet transfusion independence was defined as the longest time between the last RBC and/or platelet transfusion before the start of the RBC and/or platelet transfusion-independent period and the first RBC and/or platelet transfusion after the start of the transfusion-independent period, which occurs \>= 8 weeks later.
Analysis population: ITT Population included all participants who were randomized. Number analyzed is the number of participants who achieved transfusion independence for the specified category, with data available for analysis.
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 | 227 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 227 |
Reported measurements
Duration of RBC Transfusion Independence
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 58 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 58 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 15.6 | Not reported | 10.18 | 28.09 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 13.5 | Not reported | 9.07 | 16.66 | Not reported |
Duration of Platelet Transfusion Independence
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 22 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 15 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 14.9 | Not reported | 5.09 | 23.23 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 11.6 | Not reported | 2.73 | 16.26 | Not reported |
Duration of Transfusion Independence
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 63 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 59 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 12.0 | Not reported | 8.90 | 19.48 | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 13.5 | Not reported | 10.38 | 16.66 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.715
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.119
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of RBC Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.774
- p Value Comment
- P-value comparing duration of RBC or platelet transfusion 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
- 1.231
- statistical Method
- Log Rank
- ci Lower Limit
- 0.567
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.147
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of Platelet Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.801
- p Value Comment
- P-value comparing duration of platelet transfusion 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
- 1.533
- statistical Method
- Log Rank
- ci Lower Limit
- 0.580
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.614
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.450
- p Value Comment
- P-value comparing duration of RBC or platelet transfusion 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
- 0.968
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.715
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.119
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of RBC Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.774
- p Value Comment
- P-value comparing duration of RBC or platelet transfusion 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
- 1.231
- statistical Method
- Log Rank
- ci Lower Limit
- 0.567
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.147
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of Platelet Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.801
- p Value Comment
- P-value comparing duration of platelet transfusion 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
- 1.533
- statistical Method
- Log Rank
- ci Lower Limit
- 0.580
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.614
- estimate Comment
- HR:unadjusted Cox Proportional Hazard regression;stratification(low-blast AML,IPSS-R risk groups=very high,high,intermediate for HRMDS/CMML),treatment as factor.HR\<1:longer duration of transfusion independence in combination arm than azacitidine arm.
- group Description
- Duration of Transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.450
- p Value Comment
- P-value comparing duration of RBC or platelet transfusion 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
- 0.968
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.18
- upper Limit
- 28.09
- value
- 15.6
- group Id
- OG001
- lower Limit
- 9.07
- upper Limit
- 16.66
- value
- 13.5
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Duration of RBC Transfusion Independence
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.09
- upper Limit
- 23.23
- value
- 14.9
- group Id
- OG001
- lower Limit
- 2.73
- upper Limit
- 16.26
- value
- 11.6
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 15
- units
- Participants
- title
- Duration of Platelet Transfusion Independence
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.90
- upper Limit
- 19.48
- value
- 12.0
- group Id
- OG001
- lower Limit
- 10.38
- upper Limit
- 16.66
- value
- 13.5
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 59
- units
- Participants
- title
- Duration of Transfusion Independence
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 227
- units
- Participants
- description
- Duration of RBC and platelet transfusion independence was defined as the longest time between the last RBC and/or platelet transfusion before the start of the RBC and/or platelet transfusion-independent period and the first RBC and/or platelet transfusion after the start of the transfusion-independent period, which occurs \>= 8 weeks later.
- 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
- ITT Population included all participants who were randomized. Number analyzed is the number of participants who achieved transfusion independence for the specified category, with data available for analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Duration of Red Blood Cells (RBCs) and Duration of Platelet-transfusion Independence and Duration of Red Blood Cells (RBCs) and Platelet-transfusion Independence
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice