TriangleNCT03069352 · OUTCOME
Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)
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 the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
What was measured
The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count of \> 0.5 × 10³/μL and * Peripheral blood platelet count of \> 0.5 × 10⁵/μL and * A 1 week platelet transfusion-free period prior to the hematology lab collection. Participants with no disease assessments were considered to be non-responders.
Analysis population: Full analysis set
Groups in this outcome
Placebo + Low Dose Cytarabine (LDAC)
Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
Venetoclax + Low Dose Cytarabine (LDAC)
Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
| Group | Source count |
|---|---|
| Placebo + Low Dose Cytarabine (LDAC) | 68 |
| Venetoclax + Low Dose Cytarabine (LDAC) | 143 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Low Dose Cytarabine (LDAC) | 14.7 | Not reported | 7.3 | 25.4 | Not reported |
| Venetoclax + Low Dose Cytarabine (LDAC) | 46.9 | Not reported | 38.5 | 55.4 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
- statistical Method
- Cochran-Mantel-Haenszel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- Cochran-Mantel-Haenszel test stratified by age (18 - \< 75, ≥ 75) and AML status (de novo, secondary).
- statistical Method
- Cochran-Mantel-Haenszel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.3
- upper Limit
- 25.4
- value
- 14.7
- group Id
- OG001
- lower Limit
- 38.5
- upper Limit
- 55.4
- value
- 46.9
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 143
- units
- Participants
- description
- The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator. CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with \< 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease. CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met: * Bone marrow with \< 5% blasts and * Peripheral blood neutrophil count of \> 0.5 × 10³/μL and * Peripheral blood platelet count of \> 0.5 × 10⁵/μL and * A 1 week platelet transfusion-free period prior to the hematology lab collection. Participants with no disease assessments were considered to be non-responders.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
- id
- OG000
- title
- Placebo + Low Dose Cytarabine (LDAC)
- description
- Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
- id
- OG001
- title
- Venetoclax + Low Dose Cytarabine (LDAC)
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.
- title
- Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice