TriangleNCT02993523 · OUTCOME
Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
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
- From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
What was measured
CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count \>10\^3/ microliter (mcL), platelets \>10\^5/mcL, red cell transfusion independence, and bone marrow with \<5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10\^3/mcL or platelets ≤10\^5/mcL. Percentages are rounded off to whole number at the nearest decimal.
Analysis population: Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax. Data is reported for Group 2 and Open-label China Cohort.
Groups in this outcome
Group 2: Placebo + Azacitidine 75 mg/m^2
Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
| Group | Source count |
|---|---|
| Group 2: Placebo + Azacitidine 75 mg/m^2 | 145 |
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 286 |
| Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 10 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2: Placebo + Azacitidine 75 mg/m^2 | 17.9 | Not reported | 12.1 | 25.2 | Not reported |
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 38.8 | Not reported | 33.1 | 44.7 | Not reported |
| Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 60.0 | Not reported | 26.2 | 87.8 | Not reported |
CRi
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2: Placebo + Azacitidine 75 mg/m^2 | 11.0 | Not reported | 6.4 | 17.3 | Not reported |
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 28.0 | Not reported | 22.8 | 33.6 | Not reported |
| Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2 | 20.0 | Not reported | 2.5 | 55.6 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Comment
- Cochran-Mantel-Haenszel (CMH) test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.1
- upper Limit
- 25.2
- value
- 17.9
- group Id
- OG001
- lower Limit
- 33.1
- upper Limit
- 44.7
- value
- 38.8
- group Id
- OG002
- lower Limit
- 26.2
- upper Limit
- 87.8
- value
- 60.0
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.4
- upper Limit
- 17.3
- value
- 11.0
- group Id
- OG001
- lower Limit
- 22.8
- upper Limit
- 33.6
- value
- 28.0
- group Id
- OG002
- lower Limit
- 2.5
- upper Limit
- 55.6
- value
- 20.0
- title
- CRi
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 286
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- CR and CRi was calculated based on current International Working Group (IWG) criteria. CR is defined as absolute neutrophil count \>10\^3/ microliter (mcL), platelets \>10\^5/mcL, red cell transfusion independence, and bone marrow with \<5% blasts. CRi is defined as bone marrow with less than 5% blasts, and absolute neutrophils of ≤10\^3/mcL or platelets ≤10\^5/mcL. Percentages are rounded off to whole number at the nearest decimal.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
- id
- OG000
- title
- Group 2: Placebo + Azacitidine 75 mg/m^2
- description
- Participants received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, from Day 3 to Day 28 of each 28-day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
- id
- OG001
- title
- Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
- description
- Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
- id
- OG002
- title
- Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
- param Type
- NUMBER
- population Description
- Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort). Open-Label China Safety Cohort included participants who received at least one dose of venetoclax. Data is reported for Group 2 and Open-label China Cohort.
- reporting Status
- POSTED
- time Frame
- From the study start up to death (up to approximately 4.8 years; data cut-off date: 1 December 2021)
- title
- Percentage of Participants With Complete Remission (CR) and Complete Remission With Incomplete Marrow Recovery (CRi)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice