TriangleNCT01915498 · OUTCOME
Phase 1 Dose Expansion: Kaplan-Meier Estimate of Overall 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; 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
Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.
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 | 8.8 | Not reported | 7.5 | 10.5 | Not reported |
| Phase 1 Dose Expansion Arm 2: Enasidenib 100 mg QD | 11.6 | Not reported | 6.5 | 15.4 | Not reported |
| Phase 1 Dose Expansion Arm 3: Enasidenib 100 mg QD | 10.6 | Not reported | 6.2 | 19.8 | Not reported |
| Phase 1 Dose Expansion Arm 4: Enasidenib 100 mg QD | 11.3 | Not reported | 3.6 | 19.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 10.5
- value
- 8.8
- group Id
- OG001
- lower Limit
- 6.5
- upper Limit
- 15.4
- value
- 11.6
- group Id
- OG002
- lower Limit
- 6.2
- upper Limit
- 19.8
- value
- 10.6
- group Id
- OG003
- lower Limit
- 3.6
- upper Limit
- 19.1
- value
- 11.3
- 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
- Overall survival is defined as the time from first dose to the date of death due to any cause. Participants still alive were censored at the last date known to be alive or at the data cut-off date, whichever was earlier.
- 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 Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice