TriangleNCT00071799 · OUTCOME
Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
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
- Day 1 (randomization) to 42 months
What was measured
The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.
Analysis population: Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.
Groups in this outcome
Azacitidine
Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
Conventional Care
Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
| Group | Source count |
|---|---|
| Azacitidine | 179 |
| Conventional Care | 179 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine | 13.02 | Not reported | 9.9 | 15.0 | Not reported |
| Conventional Care | 7.61 | Not reported | 5.4 | 9.8 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0025
- p Value Comment
- The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
- statistical Method
- Log Rank
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0027
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0025
- p Value Comment
- The p value is two-sided from the log rank test stratified by the randomization stratification factors of IPSS classification and FAB classification.
- statistical Method
- Log Rank
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Cox proportional hazards model stratified on the randomization factors of FAB and IPSS with model term of treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0027
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.9
- upper Limit
- 15.0
- value
- 13.02
- group Id
- OG001
- lower Limit
- 5.4
- upper Limit
- 9.8
- value
- 7.61
- denoms
- counts
- group Id
- OG000
- value
- 179
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Azacitidine, 75 mg/m\^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
- id
- OG000
- title
- Azacitidine
- description
- Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
- id
- OG001
- title
- Conventional Care
- param Type
- MEDIAN
- population Description
- Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.
- reporting Status
- POSTED
- time Frame
- Day 1 (randomization) to 42 months
- title
- Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice