TriangleNCT05184842 · OUTCOME
Overall Survival (OS) in AML Patients
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
- At the time of censoring of data, up to ~21 months
What was measured
Median OS is reported in patients with AML at the time of censoring of data for the Primary Outcome analysis. For purposes of this study, OS refers to the duration of time from treatment initiation until a patient's death from any cause.
Analysis population: 21 patients who comprised the Primary Outcome analysis were part of the AML cohort.
Groups in this outcome
Decitabine/Venetoclax (Single Arm)
Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
| Group | Source count |
|---|---|
| Decitabine/Venetoclax (Single Arm) | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 16.1 | Not reported | 11.3 | NA | An upper limit for the 95% Confidence Interval was unable to be reached for OS due to ongoing survival in some AML patients at the time of cutoff for data analysis (i.e., \~21 months). |
Complete source fields
- classes
- categories
- measurements
- comment
- An upper limit for the 95% Confidence Interval was unable to be reached for OS due to ongoing survival in some AML patients at the time of cutoff for data analysis (i.e., \~21 months).
- group Id
- OG000
- lower Limit
- 11.3
- upper Limit
- NA
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 21
- units
- Participants
- description
- Median OS is reported in patients with AML at the time of censoring of data for the Primary Outcome analysis. For purposes of this study, OS refers to the duration of time from treatment initiation until a patient's death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 22 of each cycle (28-day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
- id
- OG000
- title
- Decitabine/Venetoclax (Single Arm)
- param Type
- MEDIAN
- population Description
- 21 patients who comprised the Primary Outcome analysis were part of the AML cohort.
- reporting Status
- POSTED
- time Frame
- At the time of censoring of data, up to ~21 months
- title
- Overall Survival (OS) in AML Patients
- type
- POST_HOC
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice