TriangleNCT03268954 · OUTCOME
Percentage of Participants With 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 42 months
What was measured
A participant was defined as RBC or platelet-transfusion independent if he/she received no RBC or platelet transfusions for a period of at least 8 weeks before the first dose of study drug through 30 days after the last dose of any study drug. Rate of transfusion independence was defined as number of participants who became transfusion independent divided by the number of participants who were transfusion dependent at Baseline.
Analysis population: ITT Population included all participants who were randomized. Overall number analyzed is the number of participants from a subset of the ITT Population who were transfusion dependent at Baseline. Number analyzed is the number of participants who were transfusion dependent at Baseline for the specified category.
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 | 140 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 129 |
Reported measurements
Percentage of Participants With RBCs-transfusion Independence
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 131 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 122 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 44.3 | Not reported | Not reported | Not reported | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 47.5 | Not reported | Not reported | Not reported | Not reported |
Percentage of Participants With Platelet-transfusion Independence
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 45 |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 48.9 | Not reported | Not reported | Not reported | Not reported |
| Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 | 45.5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -9.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.55
- group Description
- Percentage of Participants With RBC-transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.573
- p Value Comment
- P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 3.27
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -25.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.97
- group Description
- Percentage of Participants With Platelet-transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.477
- p Value Comment
- P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- -3.43
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- -9.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 15.55
- group Description
- Percentage of Participants With RBC-transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.573
- p Value Comment
- P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- 3.27
- statistical Method
- Cochran-Mantel-Haenszel
- ci Lower Limit
- -25.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 18.97
- group Description
- Percentage of Participants With Platelet-transfusion Independence
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.477
- p Value Comment
- P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test.
- param Type
- Absolute Rate Difference
- param Value
- -3.43
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- value
- 44.3
- group Id
- OG001
- value
- 47.5
- denoms
- counts
- group Id
- OG000
- value
- 131
- group Id
- OG001
- value
- 122
- units
- Participants
- title
- Percentage of Participants With RBCs-transfusion Independence
- categories
- measurements
- group Id
- OG000
- value
- 48.9
- group Id
- OG001
- value
- 45.5
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 33
- units
- Participants
- title
- Percentage of Participants With Platelet-transfusion Independence
- denoms
- counts
- group Id
- OG000
- value
- 140
- group Id
- OG001
- value
- 129
- units
- Participants
- description
- A participant was defined as RBC or platelet-transfusion independent if he/she received no RBC or platelet transfusions for a period of at least 8 weeks before the first dose of study drug through 30 days after the last dose of any study drug. Rate of transfusion independence was defined as number of participants who became transfusion independent divided by the number of participants who were transfusion dependent at Baseline.
- 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
- NUMBER
- population Description
- ITT Population included all participants who were randomized. Overall number analyzed is the number of participants from a subset of the ITT Population who were transfusion dependent at Baseline. Number analyzed is the number of participants who were transfusion dependent at Baseline for the specified category.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Percentage of Participants With Red Blood Cells (RBCs) and Platelet-transfusion Independence
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice