TriangleNCT02393859 · OUTCOME
Kaplan Meier Estimate: Overall Survival (OS)
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
- At final analysis, overall median follow-up time for OS was 55.2 months.
What was measured
OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. Months were calculated as days from randomization date to event/censor date, divided by 30.5.
Analysis population: FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Groups in this outcome
HC3 Chemotherapy
One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
Blinatumomab
One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
| Group | Source count |
|---|---|
| HC3 Chemotherapy | 57 |
| Blinatumomab | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HC3 Chemotherapy | 25.6 | Not reported | 17.5 | NA | Upper 95% CI was not estimable due to too few events. |
| Blinatumomab | NA | Not reported | NA | NA | Median and 95% CIs were not estimable due to too few events. |
Source statistical analyses
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- p Value Comment
- Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).
- param Type
- Normal score
- param Value
- -10.14
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Normal score
- param Value
- -10.32
- statistical Method
- Unstratified log-rank test
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.66
- estimate Comment
- Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Stratified HR
- param Value
- 0.33
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.65
- estimate Comment
- Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Unstratified HR
- param Value
- 0.32
Complete source fields
- analyses
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.001
- p Value Comment
- Stratification factors were: age (1 to 9 years vs other \[\< 1 year and \> 9 years\]), and marrow/MRD status (M1 with MRD level \< 10\^-3 vs M1 with MRD level ≥ 10\^-3 vs M2).
- param Type
- Normal score
- param Value
- -10.14
- statistical Method
- Stratified log-rank test
- estimate Comment
- A normal score \< 0 indicates fewer than expected events for blinatumomab relative to HC3 and therefore a longer event-free survival time.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- param Type
- Normal score
- param Value
- -10.32
- statistical Method
- Unstratified log-rank test
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.66
- estimate Comment
- Cox proportional hazard model. Stratification factors were: age and marrow/MRD status. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Stratified HR
- param Value
- 0.33
- ci Lower Limit
- 0.16
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.65
- estimate Comment
- Cox proportional hazard model. (HR \< 1.0 indicates a lower average event rate and a longer survival for blinatumomab relative to HC3.)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Unstratified HR
- param Value
- 0.32
- classes
- categories
- measurements
- comment
- Upper 95% CI was not estimable due to too few events.
- group Id
- OG000
- lower Limit
- 17.5
- upper Limit
- NA
- value
- 25.6
- comment
- Median and 95% CIs were not estimable due to too few events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- OS was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive. Months were calculated as days from randomization date to event/censor date, divided by 30.5.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- One week of treatment with HC3 followed by 3 weeks of no treatment. The standard intensive consolidation chemotherapy course HC3 includes dexamethasone (10 mg/m\^2/day IV on Days 1-6), vincrisitne (1.5 mg/m\^2/day IV on Days 1 and 6), daunorubicin (30 mg/m\^2 IV over 24 hours on Day 5), methotrexate (1 g/m\^2 IV over 36 hours on Day 1), ifosfamide (800 mg/m\^2 IV for 1 hour on Days 2-4), and pegylated \[PEG\]-asparaginase (1000 U/m\^2 IV for 2 hours or IM on Day 6) or, if allergic, erwinia-asparaginase (20,000 units/m\^2 IV or IM every 48 hours for a total of 6 doses).
- id
- OG000
- title
- HC3 Chemotherapy
- description
- One 4-week cycle of blinatumomab 15 μg/m\^2/day as a continuous intravenous infusion (CIVI).
- id
- OG001
- title
- Blinatumomab
- param Type
- MEDIAN
- population Description
- FAS: randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
- reporting Status
- POSTED
- time Frame
- At final analysis, overall median follow-up time for OS was 55.2 months.
- title
- Kaplan Meier Estimate: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice