TriangleNCT01696084 · OUTCOME
Event-free Survival
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 the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first
What was measured
All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
Analysis population: Intent-to-Treat (ITT) Population: All participants randomized in the study.
Groups in this outcome
Arm A (CPX-351)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
Arm B (7+3)
Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
| Group | Source count |
|---|---|
| Arm A (CPX-351) | 153 |
| Arm B (7+3) | 156 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (CPX-351) | 2.53 | Not reported | 2.07 | 4.99 | Not reported |
| Arm B (7+3) | 1.31 | Not reported | 1.08 | 1.64 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.07
- upper Limit
- 4.99
- value
- 2.53
- group Id
- OG001
- lower Limit
- 1.08
- upper Limit
- 1.64
- value
- 1.31
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 156
- units
- Participants
- description
- All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
- id
- OG000
- title
- Arm A (CPX-351)
- description
- Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
- id
- OG001
- title
- Arm B (7+3)
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population: All participants randomized in the study.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first
- title
- Event-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice