TriangleNCT02287233 · OUTCOME
Duration of Post Baseline Transfusion Independence
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months.
What was measured
The duration of transfusion independence is defined as the first time period that a participant received no RBC/platelet transfusions for at least 56 days during the evaluation period. Post-baseline transfusion independence is defined as a period of at least 56 days with no RBC or platelet transfusion during the evaluation period. The evaluation period is from the first dose of study drug to the last dose of study drug until the 30 day follow-up visit, disease progression (including clinical progression), or death, whichever was earlier.
Analysis population: Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who achieved post-baseline RBC or platelet transfusion independence overall (50), RBC and platelet transfusion independence (37), RBC transfusion independence (39), or platelet transfusion independence (48).
Groups in this outcome
Phase 1+2: 600 mg Venetoclax + LDAC
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
| Group | Source count |
|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 50 |
Reported measurements
Duration of RBC and platelet transfusion independence
| Group | Source count |
|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 37 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 150 | Not reported | 56 | 1855 | Not reported |
Duration of RBC transfusion independence
| Group | Source count |
|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 39 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 123 | Not reported | 56 | 1881 | Not reported |
Duration of platelet transfusion independence
| Group | Source count |
|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 48 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 155.5 | Not reported | 56 | 1855 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 1855
- value
- 150
- denoms
- counts
- group Id
- OG000
- value
- 37
- units
- Participants
- title
- Duration of RBC and platelet transfusion independence
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 1881
- value
- 123
- denoms
- counts
- group Id
- OG000
- value
- 39
- units
- Participants
- title
- Duration of RBC transfusion independence
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56
- upper Limit
- 1855
- value
- 155.5
- denoms
- counts
- group Id
- OG000
- value
- 48
- units
- Participants
- title
- Duration of platelet transfusion independence
- denoms
- counts
- group Id
- OG000
- value
- 50
- units
- Participants
- description
- The duration of transfusion independence is defined as the first time period that a participant received no RBC/platelet transfusions for at least 56 days during the evaluation period. Post-baseline transfusion independence is defined as a period of at least 56 days with no RBC or platelet transfusion during the evaluation period. The evaluation period is from the first dose of study drug to the last dose of study drug until the 30 day follow-up visit, disease progression (including clinical progression), or death, whichever was earlier.
- dispersion Type
- Full Range
- groups
- description
- Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
- id
- OG000
- title
- Phase 1+2: 600 mg Venetoclax + LDAC
- param Type
- MEDIAN
- population Description
- Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who achieved post-baseline RBC or platelet transfusion independence overall (50), RBC and platelet transfusion independence (37), RBC transfusion independence (39), or platelet transfusion independence (48).
- reporting Status
- POSTED
- time Frame
- From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months.
- title
- Duration of Post Baseline Transfusion Independence
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice