TriangleNCT01757535 · OUTCOME
Kaplan-Meier Estimate of Relapse Free Survival (RFS)
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 day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
What was measured
RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \[myeloblasts\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.
Analysis population: The intent to treat population includes participants who were randomized, regardless of whether they received treatment or not.
Groups in this outcome
Oral Azacitidine Plus Best Supportive Care
Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
| Group | Source count |
|---|---|
| Oral Azacitidine Plus Best Supportive Care | 238 |
| Placebo Plus Best Supportive Care | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine Plus Best Supportive Care | 10.2 | Not reported | 7.9 | 12.9 | Not reported |
| Placebo Plus Best Supportive Care | 4.8 | Not reported | 4.6 | 6.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- estimate Comment
- The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- p Value Comment
- The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.9
- upper Limit
- 12.9
- value
- 10.2
- group Id
- OG001
- lower Limit
- 4.6
- upper Limit
- 6.4
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 234
- units
- Participants
- description
- RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \[myeloblasts\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG000
- title
- Oral Azacitidine Plus Best Supportive Care
- description
- Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
- id
- OG001
- title
- Placebo Plus Best Supportive Care
- param Type
- MEDIAN
- population Description
- The intent to treat population includes participants who were randomized, regardless of whether they received treatment or not.
- reporting Status
- POSTED
- time Frame
- From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
- title
- Kaplan-Meier Estimate of Relapse Free Survival (RFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice