TriangleNCT01915498 · OUTCOME
Phase 2: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
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
- Not reported
- Time frame
- Baseline to the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).
What was measured
Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 56 days before the first dose date for Phase 2.
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
Baseline Transfusion Dependent
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 67 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Enasidenib 100 mg QD | 41.8 | Not reported | Not reported | Not reported | Not reported |
Baseline Transfusion Independent
| Group | Source count |
|---|---|
| Phase 2: Enasidenib 100 mg QD | 38 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Enasidenib 100 mg QD | 57.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 41.8
- denoms
- counts
- group Id
- OG000
- value
- 67
- units
- Participants
- title
- Baseline Transfusion Dependent
- categories
- measurements
- group Id
- OG000
- value
- 57.9
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- title
- Baseline Transfusion Independent
- denoms
- counts
- group Id
- OG000
- value
- 105
- units
- Participants
- description
- Participants who achieved 56-day post-baseline red blood cell (RBC) transfusion independence, i.e. with no RBC transfusions for at least 56 consecutive days during the treatment exposure period, reported by Baseline RBC transfusion dependence status. Participants with at least one transfusion during the Baseline period were considered transfusion dependent at Baseline, where the Baseline period is defined as 56 days before the first dose date for Phase 2.
- 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
- NUMBER
- 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
- Baseline to the end of treatment; median duration of treatment exposure in Phase 2 was 5.3 months (range 0.4 to 22.5 months).
- title
- Phase 2: Percentage of Participants Who Achieved 56-Day Red Blood Cell Transfusion Independence Post-baseline
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice