TriangleNCT02610777 · OUTCOME
Time to Subsequent Therapy
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 date of randomization up to approximately 5 years
What was measured
Time to subsequent therapy is defined as time from randomization to the date of the first subsequent therapy. Subsequent therapy is defined as agent(s) with antileukemic/anti-MDS activity. Participants who discontinue study treatment to receive single-agent azacitidine off study did not be counted as receiving subsequent therapy.
Analysis population: ITT Population was defined as all participants who were randomized.
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 | 62 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | NA | Not reported | NA | NA | The median and 95% CI was not estimable due to low number of participants with the event. |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | NA | Not reported | NA | NA | The median and 95% CI was not estimable due to lower number of participants with the event. |
Source statistical analyses
- ci Lower Limit
- 0.226
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.620
- estimate Comment
- HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.888
- p Value Comment
- P-value is from an unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.905
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.226
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.620
- estimate Comment
- HR is based on an unstratified Cox proportional hazard regression model with treatment as a factor. HR\<1for the treatment indicates a longer time to Subsequent Therapy in the Pevonedistat Combination arm compared to the Azacitidine only arm.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- =0.888
- p Value Comment
- P-value is from an unstratified log-rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.905
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The median and 95% CI was not estimable due to low number of participants with the event.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and 95% CI was not estimable due to lower number of participants with the event.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- Time to subsequent therapy is defined as time from randomization to the date of the first subsequent therapy. Subsequent therapy is defined as agent(s) with antileukemic/anti-MDS activity. Participants who discontinue study treatment to receive single-agent azacitidine off study did not be counted as receiving subsequent therapy.
- dispersion Type
- 95% Confidence Interval
- 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
- ITT Population was defined as all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From date of randomization up to approximately 5 years
- title
- Time to Subsequent Therapy
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice