TriangleNCT02287233 · OUTCOME
Complete Remission With Partial Hematologic Recovery (CRh) Rate
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
- 95% Confidence Interval
- Time frame
- Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.
What was measured
Complete remission with partial hematologic recovery is a derived response based on bone marrow blast and hematology laboratory values. CRh rate is defined as the percentage of participants who achieved CRh as the best response at any time point during the study. A participant achieved a CRh when meeting the following criteria: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count of \> 0.5 × 10\^3 /µL and * Peripheral blood platelet count of \> 0.5 × 10\^5 /µL and * A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection. Participants who never achieved CRh or did not have disease assessment or hematology data were considered to be non-responders in the calculation of CRh rate.
Analysis population: All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)
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 | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1+2: 600 mg Venetoclax + LDAC | 20.7 | Not reported | 12.6 | 31.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.6
- upper Limit
- 31.1
- value
- 20.7
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- Complete remission with partial hematologic recovery is a derived response based on bone marrow blast and hematology laboratory values. CRh rate is defined as the percentage of participants who achieved CRh as the best response at any time point during the study. A participant achieved a CRh when meeting the following criteria: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count of \> 0.5 × 10\^3 /µL and * Peripheral blood platelet count of \> 0.5 × 10\^5 /µL and * A 1 week (≥ 7 days) platelet transfusion-free period prior to the hematology lab collection. Participants who never achieved CRh or did not have disease assessment or hematology data were considered to be non-responders in the calculation of CRh rate.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- population Description
- All enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg)
- reporting Status
- POSTED
- time Frame
- Response was assessed at Cycle 2, Day 1, Cycle 4, Day 1, and every 3 cycles thereafter; median duration of treatment was 4.2 months.
- title
- Complete Remission With Partial Hematologic Recovery (CRh) Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice