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NCT05059262 · ADVERSE EVENTS

Adverse events

Study of Vimseltinib for Tenosynovial Giant Cell Tumor · Source last updated 2026-03-20

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
Collection of adverse events started from the signing of informed consent through safety follow-up (up to 1.68 years)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Total - Vimseltinib

Participants received blinded treatment of vimseltinib 30 mg BIW for 24 weeks in Part 1 and/or open-label vimseltinib 30 mg BIW in Part 2 until EoT.

17 / 118113 / 1181 / 118
Placebo

Participants received blinded treatment of matching placebo BIW for 24 weeks.

1 / 3932 / 390 / 39

Group identifiers: EG000: Total - Vimseltinib · EG001: 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 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Myocardial ischaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Uveitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      118
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Inguinal hernia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      118
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      118
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Localised infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Paronychia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Rhinovirus infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Subcutaneous abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Viral infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Ankle fracture

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      118
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      118
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      118
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Eyelid oedema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      118
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Lacrimation increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      118
      num Events
      87
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      6
    term
    Periorbital oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      118
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      118
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      118
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      118
      num Events
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      8
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      118
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      118
      num Events
      33
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      9
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      118
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Vomiting
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    118
    description
    Participants received blinded treatment of vimseltinib 30 mg BIW for 24 weeks in Part 1 and/or open-label vimseltinib 30 mg BIW in Part 2 until EoT.
    id
    EG000
    other Num Affected
    113
    other Num At Risk
    118
    serious Num Affected
    17
    serious Num At Risk
    118
    title
    Total - Vimseltinib
  2. deaths Num Affected
    0
    deaths Num At Risk
    39
    description
    Participants received blinded treatment of matching placebo BIW for 24 weeks.
    id
    EG001
    other Num Affected
    32
    other Num At Risk
    39
    serious Num Affected
    1
    serious Num At Risk
    39
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      118
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      118
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Dry eye
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      118
      num Events
      19
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Eyelid oedema
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      118
      num Events
      12
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Lacrimation increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      118
      num Events
      87
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      39
      num Events
      6
    term
    Periorbital oedema
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      118
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Vision blurred
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      118
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      39
      num Events
      4
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      118
      num Events
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      118
      num Events
      20
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      39
      num Events
      8
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      118
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      39
      num Events
      2
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      118
      num Events
      33
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      39
      num Events
      9
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      118
      num Events
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Myocardial ischaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Uveitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      118
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Inguinal hernia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      118
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      39
      num Events
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      118
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Cellulitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Localised infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Paronychia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Rhinovirus infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Subcutaneous abscess
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Viral infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      118
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      39
      num Events
      0
    term
    Ankle fracture
time Frame
Collection of adverse events started from the signing of informed consent through safety follow-up (up to 1.68 years)

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