TriangleNCT03922100 · OUTCOME
For AML and in Phase II Only: Overall Response Rate (ORR: CRc + CRh + MLFS + PR)
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 CRi or MLFS 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 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Defined as the number of participants who achieved CRi or MLFS 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: Overall Response Rate (ORR: CRc + CRh + MLFS + PR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice