TriangleNCT05184842 · OUTCOME
Duration of Response (DOR) in HR-MDS 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 DOR was determined for HR-MDS patients who comprised the Primary Outcome Measure analysis. DOR was evaluated from the time of response after 12 weeks of induction until disease progression.
Analysis population: 6 patients who comprised the Primary Outcome analysis were part of the HR-MDS 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) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 5.2 | Not reported | 4.8 | NA | An upper limit for the 95% Confidence Interval for DOR was unable to be reached due to some HR-MDS patients continuing to respond to treatment 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 for DOR was unable to be reached due to some HR-MDS patients continuing to respond to treatment at the time of cutoff for data analysis (i.e., \~21 months).
- group Id
- OG000
- lower Limit
- 4.8
- upper Limit
- NA
- value
- 5.2
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Median DOR was determined for HR-MDS patients who comprised the Primary Outcome Measure analysis. DOR was evaluated from the time of response after 12 weeks of induction until disease progression.
- 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
- 6 patients who comprised the Primary Outcome analysis were part of the HR-MDS cohort.
- reporting Status
- POSTED
- time Frame
- At the time of censoring of data, up to ~21 months
- title
- Duration of Response (DOR) in HR-MDS Patients
- type
- POST_HOC
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice