TriangleNCT01915498 · OUTCOME
Phase 2 Dose Expansion: Kaplan-Meier Estimate of 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 first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).
What was measured
Event-free survival is defined as the interval from the date of the first dose to the date of documented relapse, progression, or death due to any cause, whichever occurred first. Participants without an EFS event were censored at the date of the last adequate response assessment.
Analysis population: All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
Groups in this outcome
Phase 2: Enasidenib 100 mg QD
Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Enasidenib 100 mg QD | 4.7 | Not reported | 3.0 | 5.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.0
- upper Limit
- 5.6
- value
- 4.7
- denoms
- counts
- group Id
- OG000
- value
- 105
- units
- Participants
- description
- Event-free survival is defined as the interval from the date of the first dose to the date of documented relapse, progression, or death due to any cause, whichever occurred first. Participants without an EFS event were censored at the date of the last adequate response assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enasidenib 100 mg QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG000
- title
- Phase 2: Enasidenib 100 mg QD
- param Type
- MEDIAN
- population Description
- All participants In Phase 2 with R/R AML who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From first dose of study treatment to the data cut-off date of 01 September 2017; median time on follow-up in Phase 2 was 5.8 months (range 0.4 to 22.5 months).
- title
- Phase 2 Dose Expansion: Kaplan-Meier Estimate of Event Free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice