Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03785964 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 years and 4 months and up to 2 years and 10 months. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.
Other-event reporting threshold
5%

One patient randomized to Nirogacestat arm, discontinued prior to receiving any study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Double-Blind Phase - Nirogacestat

Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet

14 / 6969 / 690 / 69
Double-Blind Phase - Placebo

Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet

8 / 7269 / 721 / 72

Group identifiers: EG000: Double-Blind Phase - Nirogacestat · EG001: Double-Blind Phase - Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial Fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Duodenal perforation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Gastrointestinal fistula
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Cholecystitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Drug-induced liver injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Appendicitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      72
      num Events
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      4
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      69
      num Events
      16
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
      num Events
      18
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
      num Events
      8
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      69
      num Events
      129
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      72
      num Events
      32
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      69
      num Events
      53
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      72
      num Events
      32
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      69
      num Events
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Stomatitis
Complete source fields
description
One patient randomized to Nirogacestat arm, discontinued prior to receiving any study drug.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    69
    description
    Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
    id
    EG000
    other Num Affected
    69
    other Num At Risk
    69
    serious Num Affected
    14
    serious Num At Risk
    69
    title
    Double-Blind Phase - Nirogacestat
  2. deaths Num Affected
    1
    deaths Num At Risk
    72
    description
    Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
    id
    EG001
    other Num Affected
    69
    other Num At Risk
    72
    serious Num Affected
    8
    serious Num At Risk
    72
    title
    Double-Blind Phase - Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      72
      num Events
      18
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      4
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      69
      num Events
      16
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      72
      num Events
      18
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      69
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      72
      num Events
      8
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      69
      num Events
      129
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      72
      num Events
      32
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      69
      num Events
      9
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      72
      num Events
      6
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      69
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      69
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      69
      num Events
      53
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      72
      num Events
      32
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      69
      num Events
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Stomatitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Atrial Fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Duodenal perforation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Gastrointestinal fistula
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Stomatitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Cholecystitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      69
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Drug-induced liver injury
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Abdominal infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      69
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      72
      num Events
      0
    term
    Appendicitis
time Frame
All SAEs and AEs were collected from the time of signing ICF until 30 days after the last dose of study treatment, an average of 1 years and 4 months and up to 2 years and 10 months. Medical occurrences that begin before the start of study treatment but after obtaining informed consent will be recorded as AEs.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice