TriangleNCT03922100 · OUTCOME
For AML and in Phase II Only: Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh) Rate
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
- From the date of first response up to end of study (approximately 1.5 years)
What was measured
Defined as the number of participants who achieved a CR or CRh or CRi as best response, divided by the number of participants in the analysis population.
Analysis population: Patients evaluable for efficacy analysis (efficacy dataset):For Cohort 1 and Cohort 2, only the subset of participants with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.
Groups in this outcome
Phase 2, Schedule B, Cohort 1:360+150 mg
Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
Phase 2, Schedule B, Cohort 2: 360+150 mg
Participants who had failed standard of care. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
| Group | Source count |
|---|---|
| Phase 2, Schedule B, Cohort 1:360+150 mg | 3 |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2, Schedule B, Cohort 1:360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2, Schedule B, Cohort 2: 360+150 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Defined as the number of participants who achieved a CR or CRh or CRi as best response, divided by the number of participants in the analysis population.
- groups
- description
- Participants who had failed standard of care including Venetoclax and Gilteritining based therapies. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
- id
- OG000
- title
- Phase 2, Schedule B, Cohort 1:360+150 mg
- description
- Participants who had failed standard of care. NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards
- id
- OG001
- title
- Phase 2, Schedule B, Cohort 2: 360+150 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Patients evaluable for efficacy analysis (efficacy dataset):For Cohort 1 and Cohort 2, only the subset of participants with FLT3-ITD mutation and no D835 mutation based on the central test were included in this population.
- reporting Status
- POSTED
- time Frame
- From the date of first response up to end of study (approximately 1.5 years)
- title
- For AML and in Phase II Only: Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh) Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice