TriangleNCT00549848 · OUTCOME
Probability of Event-free Survival
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
- 95% Confidence Interval
- Time frame
- For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
What was measured
To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111). EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission.
Analysis population: Per protocol this objective is to study whether intensifying induction will result in improved outcome compared to TOTXV. All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.
Groups in this outcome
TOTXVI PEG 3500
Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
TOTXVI PEG 2500
Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
TOTXVI Not Randomized
Patients who came off study prior to randomization
All Eligible Patients in TOTXV
All 498 eligible children with ALL who are treated with risk-directed therapy.
| Group | Source count |
|---|---|
| TOTXVI PEG 3500 | 201 |
| TOTXVI PEG 2500 | 205 |
| TOTXVI Not Randomized | 180 |
| All Eligible Patients in TOTXV | 498 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TOTXVI PEG 3500 | 92.4 | Not reported | 88.7 | 96.1 | Not reported |
| TOTXVI PEG 2500 | 91.1 | Not reported | 87.0 | 95.2 | Not reported |
| TOTXVI Not Randomized | 86.3 | Not reported | 78.9 | 93.7 | Not reported |
| All Eligible Patients in TOTXV | 87.1 | Not reported | 84.2 | 90.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 88.7
- upper Limit
- 96.1
- value
- 92.4
- group Id
- OG001
- lower Limit
- 87.0
- upper Limit
- 95.2
- value
- 91.1
- group Id
- OG002
- lower Limit
- 78.9
- upper Limit
- 93.7
- value
- 86.3
- group Id
- OG003
- lower Limit
- 84.2
- upper Limit
- 90.0
- value
- 87.1
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 205
- group Id
- OG002
- value
- 180
- group Id
- OG003
- value
- 498
- units
- Participants
- description
- To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111). EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
- id
- OG000
- title
- TOTXVI PEG 3500
- description
- Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
- id
- OG001
- title
- TOTXVI PEG 2500
- description
- Patients who came off study prior to randomization
- id
- OG002
- title
- TOTXVI Not Randomized
- description
- All 498 eligible children with ALL who are treated with risk-directed therapy.
- id
- OG003
- title
- All Eligible Patients in TOTXV
- param Type
- NUMBER
- population Description
- Per protocol this objective is to study whether intensifying induction will result in improved outcome compared to TOTXV. All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.
- reporting Status
- POSTED
- time Frame
- For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
- title
- Probability of Event-free Survival
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice