TriangleNCT01915498 · OUTCOME
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Event Free Survival (EFS)
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; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 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 occurs first. Participants without an EFS event were censored at the date of the last adequate response assessment.
Analysis population: All participants in Phase 1 Dose Expansion who received at least one dose of study treatment.
Groups in this outcome
Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD | 49 |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 25 |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 25 |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Expansion Arm 1: Enasidenib 100 mg QD | 4.0 | Not reported | 3.8 | 7.0 | Not reported |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 3.8 | Not reported | 2.6 | 8.8 | Not reported |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 9.2 | Not reported | 2.8 | NA | Not estimable due to the low number of events |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 3.8 | Not reported | 1.8 | 11.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.8
- upper Limit
- 7.0
- value
- 4.0
- group Id
- OG001
- lower Limit
- 2.6
- upper Limit
- 8.8
- value
- 3.8
- comment
- Not estimable due to the low number of events
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 9.2
- group Id
- OG003
- lower Limit
- 1.8
- upper Limit
- 11.3
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 25
- group Id
- OG003
- value
- 27
- 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 occurs 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 ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib 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 1 Dose Expansion Arm 1: Enasidenib 100 mg QD
- description
- Participants \< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG001
- title
- Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD
- description
- Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG002
- title
- Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD
- description
- Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
- id
- OG003
- title
- Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD
- param Type
- MEDIAN
- population Description
- All participants in Phase 1 Dose Expansion who received at least one 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; overall median time on follow-up in Phase 1 Dose Expansion was 8.3 months (range 0.5 to 32.8 months).
- title
- Phase 1 Dose Expansion: Kaplan-Meier Estimate of Event Free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice