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NCT03785964 · FLOW

Participant flow

Nirogacestat for Adults With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) · Source last updated 2026-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
    id
    FG000
    title
    Double-Blind Phase - Nirogacestat
  2. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Unqualified Clinical Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Not treated
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        11
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        23
      type
      Ongoing (still on treatment) pertains to treatment status at the time of the primary analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        72
      type
      Treated (Safety Population)
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. 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
    4. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
    id
    FG000
    title
    Double-Blind Phase - Nirogacestat
  2. 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
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Unqualified Clinical Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Not treated
    5. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        11
      type
      Other reason
    6. reasons
      1. group Id
        FG000
        num Subjects
        36
      2. group Id
        FG001
        num Subjects
        23
      type
      Ongoing (still on treatment) pertains to treatment status at the time of the primary analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      2. group Id
        FG001
        num Subjects
        72
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        72
      type
      Treated (Safety Population)
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. 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
    4. achievements
      1. group Id
        FG000
        num Subjects
        58
      2. group Id
        FG001
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice