NCT03922100 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG000
- title
- Phase 1, Schedule A: 20 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG001
- title
- Phase 1, Schedule A: 40 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG002
- title
- Phase 1, Schedule A: 80 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG003
- title
- Phase 1, Schedule A: 120 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG004
- title
- Phase 1, Schedule A: 180 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG005
- title
- Phase 1, Schedule A: 270 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG006
- title
- Phase 1, Schedule A: 300 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG007
- title
- Phase 1, Schedule A: 360 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- FG008
- title
- Phase 1, Schedule B: 120 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
- id
- FG009
- title
- Phase 1, Schedule B: 180 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- FG010
- title
- Phase 1, Schedule B: 250 mg
- 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
- FG011
- title
- Phase 2, Schedule B, Cohort 1:360+150 mg
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Study Terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 8
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 1
- type
- Disease progression or relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Eligibility for hemopoietic Stem cell transplantation
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- First cycle dose limiting toxicity
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Unacceptable drug related toxicities Incompatible with Continuation of NMS-03592088
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Myasthenic syndrome with Systemic and/or bulbar Impairment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 4
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 6
- group Id
- FG010
- num Subjects
- 4
- group Id
- FG011
- num Subjects
- 5
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 4
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 6
- group Id
- FG010
- num Subjects
- 4
- group Id
- FG011
- num Subjects
- 5
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG000
- title
- Phase 1, Schedule A: 20 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG001
- title
- Phase 1, Schedule A: 40 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG002
- title
- Phase 1, Schedule A: 80 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
- id
- FG003
- title
- Phase 1, Schedule A: 120 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG004
- title
- Phase 1, Schedule A: 180 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG005
- title
- Phase 1, Schedule A: 270 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG006
- title
- Phase 1, Schedule A: 300 mg
- description
- All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
- id
- FG007
- title
- Phase 1, Schedule A: 360 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- FG008
- title
- Phase 1, Schedule B: 120 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
- id
- FG009
- title
- Phase 1, Schedule B: 180 mg
- description
- All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
- id
- FG010
- title
- Phase 1, Schedule B: 250 mg
- 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
- FG011
- title
- Phase 2, Schedule B, Cohort 1:360+150 mg
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Study Terminated by Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 8
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 2
- group Id
- FG011
- num Subjects
- 1
- type
- Disease progression or relapse
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 1
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Eligibility for hemopoietic Stem cell transplantation
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 1
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- First cycle dose limiting toxicity
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 1
- type
- Unacceptable drug related toxicities Incompatible with Continuation of NMS-03592088
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Myasthenic syndrome with Systemic and/or bulbar Impairment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 3
- group Id
- FG005
- num Subjects
- 4
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 6
- group Id
- FG010
- num Subjects
- 4
- group Id
- FG011
- num Subjects
- 5
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
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- FG002
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- FG003
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- FG004
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- FG005
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- FG006
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- FG007
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- FG009
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- FG010
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- FG011
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- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
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- 3
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- 3
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- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle