NCT03785964 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- id
- FG000
- title
- Double-Blind Phase - Nirogacestat
- description
- Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
- id
- FG001
- title
- Double-Blind Phase - Placebo
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 14
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Unqualified Clinical Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Participant non-compliance
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Not treated
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 11
- type
- Other reason
- reasons
- group Id
- FG000
- num Subjects
- 36
- group Id
- FG001
- num Subjects
- 23
- type
- Ongoing (still on treatment) pertains to treatment status at the time of the primary analysis
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 70
- group Id
- FG001
- num Subjects
- 72
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 69
- group Id
- FG001
- num Subjects
- 72
- type
- Treated (Safety Population)
- achievements
- group Id
- FG000
- num Subjects
- 12
- group Id
- FG001
- num Subjects
- 35
- comment
- Completed participants met the study endpoint. Information for completed and not completed pertains to treatment status at the time of the primary analysis. The open-label extension is ongoing.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 58
- group Id
- FG001
- num Subjects
- 37
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- id
- FG000
- title
- Double-Blind Phase - Nirogacestat
- description
- Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
- id
- FG001
- title
- Double-Blind Phase - Placebo
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 14
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Unqualified Clinical Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- type
- Participant non-compliance
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Not treated
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 11
- type
- Other reason
- reasons
- group Id
- FG000
- num Subjects
- 36
- group Id
- FG001
- num Subjects
- 23
- type
- Ongoing (still on treatment) pertains to treatment status at the time of the primary analysis
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 70
- group Id
- FG001
- num Subjects
- 72
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 69
- group Id
- FG001
- num Subjects
- 72
- type
- Treated (Safety Population)
- achievements
- group Id
- FG000
- num Subjects
- 12
- group Id
- FG001
- num Subjects
- 35
- comment
- Completed participants met the study endpoint. Information for completed and not completed pertains to treatment status at the time of the primary analysis. The open-label extension is ongoing.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 58
- group Id
- FG001
- num Subjects
- 37
- type
- NOT COMPLETED
- title
- Overall Study
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Preserved source evidence · Not medical advice
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