TriangleNCT02993523 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
What was measured
OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.
Analysis population: Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety 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).
| 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 2: Placebo + Azacitidine 75 mg/m^2 | 9.6 | Not reported | 7.4 | 12.7 | Not reported |
| Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 | 14.7 | Not reported | 12.1 | 18.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.465
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.723
- estimate Comment
- HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.580
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.465
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.723
- estimate Comment
- HR from Cox proportional hazards model stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- Stratified log-rank test stratified by age (18 - \< 75, ≥ 75) and cytogenetic risk (intermediate, poor).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.580
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.4
- upper Limit
- 12.7
- value
- 9.6
- group Id
- OG001
- lower Limit
- 12.1
- upper Limit
- 18.7
- value
- 14.7
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 286
- units
- Participants
- description
- OS is defined as the number of days from the date of randomization to the date of death. Log rank test was used to compare the OS distribution between two treatment arms. Cox regression was used to report the hazard ratio.
- 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
- param Type
- MEDIAN
- population Description
- Full Analysis Set included all Group 2 participants randomized by IVRS/IWRS (exclude the open-label China safety cohort).
- reporting Status
- POSTED
- time Frame
- From the study start up to death or alive or lost to follow-up (up to approximately 4.8 years; data cut off date: 1 December 2021)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice