TriangleNCT05184842 · OUTCOME
Percentage of Participants Who Are Able to Continue on Treatment Without Dose Interruptions or Delays
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 weeks
What was measured
The percentage of participants who are able to continue on treatment without dose interruptions or delays was defined as not having to delay or interrupt treatment due to toxicity or intolerability for more than two weeks during the 12-week induction period.
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 28 of each cycle (28day 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) | 31 |
Reported measurements
Patients able to continue treatment during induction period without dose interruptions or delays
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 28 | Not reported | Not reported | Not reported | Not reported |
Patients who missed one or more doses during induction period
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 3 | Not reported | Not reported | Not reported | Not reported |
Patients requiring dose reduction(s) during induction period
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Decitabine/Venetoclax (Single Arm) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- title
- Patients able to continue treatment during induction period without dose interruptions or delays
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Patients who missed one or more doses during induction period
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Patients requiring dose reduction(s) during induction period
- denoms
- counts
- group Id
- OG000
- value
- 31
- units
- Participants
- description
- The percentage of participants who are able to continue on treatment without dose interruptions or delays was defined as not having to delay or interrupt treatment due to toxicity or intolerability for more than two weeks during the 12-week induction period.
- 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 28 of each cycle (28day 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
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 12 weeks
- title
- Percentage of Participants Who Are Able to Continue on Treatment Without Dose Interruptions or Delays
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice