NCT02112916 · OUTCOME
EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
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
- 3 years
What was measured
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact.
Analysis population: T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%
Groups in this outcome
AALL1231 T-ALL Patients
T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
AALL0434 T-ALL Patients
T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);
| Group | Source count |
|---|---|
| AALL1231 T-ALL Patients | 229 |
| AALL0434 T-ALL Patients | 634 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AALL1231 T-ALL Patients | 88.3 | Not reported | 83.2 | 93.4 | Not reported |
| AALL0434 T-ALL Patients | 88.8 | Not reported | 86.3 | 91.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 83.2
- upper Limit
- 93.4
- value
- 88.3
- group Id
- OG001
- lower Limit
- 86.3
- upper Limit
- 91.4
- value
- 88.8
- denoms
- counts
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 634
- units
- Participants
- description
- EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- T-ALL patients on AALL1231 who did not receive prophylactic cranial radiation and did not receive bortezomib: Intermediate Risk T-ALL (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 Low Risk definition).
- id
- OG000
- title
- AALL1231 T-ALL Patients
- description
- T-ALL patients on AALL0434 \[NCT00408005\] who received prophylactic cranial radiation and did not receive nelarabine (exclude Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%);
- id
- OG001
- title
- AALL0434 T-ALL Patients
- param Type
- NUMBER
- population Description
- T-ALL patients on AALL1231 who did not receive CRT or bortezomib: IR (exclude CNS3) and SR T-ALL (exclude those who met AALL0434 \[NCT00408005\] Low Risk definition). T-ALL on AALL0434 \[NCT00408005\] (who received CRT, no nelarabine) excluding Low Risk, CNS3, M3 Day 29, and EOC MRD \>0.1%
- reporting Status
- POSTED
- time Frame
- 3 years
- title
- EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice
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