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NCT03295396 · ADVERSE EVENTS

Adverse events

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma · Source last updated 2025-07-28

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
From the time/date of initiation of study treatment through 30 days following cessation of study treatment (regardless of treatment duration), or for duration of study treatment until initiation of other anticancer therapy, whichever occurred first, up to 51 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A

Patients received 625 mg dordaviprone (ONC201) once weekly. Arm A included patients with recurrent H3 K27M-mutant glioma including those with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, and some atypical histologies.

17 / 4342 / 4333 / 43
Arm B

Patients received 625 mg dordaviprone (ONC201) once weekly. Arm B included patients with recurrent H3 K27M-mutant glioma, but excluded patients with the following: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg

7 / 3027 / 3025 / 30

Group identifiers: EG000: Arm A · EG001: Arm B

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
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Sinus tachycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Eye pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Dysphagia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Pyrexia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Pneumonia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Sepsis
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Urinary tract infection

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
      4
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Vision blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    term
    Nausea
  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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      30
    term
    Fatigue
Complete source fields
event Groups
  1. deaths Num Affected
    33
    deaths Num At Risk
    43
    description
    Patients received 625 mg dordaviprone (ONC201) once weekly. Arm A included patients with recurrent H3 K27M-mutant glioma including those with diffuse intrinsic pontine glioma (DIPG), primary spinal tumors, and some atypical histologies.
    id
    EG000
    other Num Affected
    42
    other Num At Risk
    43
    serious Num Affected
    17
    serious Num At Risk
    43
    title
    Arm A
  2. deaths Num Affected
    25
    deaths Num At Risk
    30
    description
    Patients received 625 mg dordaviprone (ONC201) once weekly. Arm B included patients with recurrent H3 K27M-mutant glioma, but excluded patients with the following: * Primary malignant lesion located in the pons or spinal cord. * Atypical non-astrocytic histologies such as ependymoma, ganglioma and pleomorphic xanthoastrocytoma, or pilocytic astrocytoma and subependymal giant cell astrocytoma (SEGA). * Prior bevacizumab treatment of \>4 doses of \>7.5 mg/kg
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    30
    serious Num Affected
    7
    serious Num At Risk
    30
    title
    Arm B
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
      4
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      30
    term
    Diplopia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Vision blurred
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      30
    term
    Nausea
  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
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      30
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      30
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Sinus tachycardia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Eye pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Dysphagia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Death
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Gait disturbance
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      43
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
    term
    Pyrexia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Pneumonia
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Sepsis
  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
      43
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
    term
    Urinary tract infection
time Frame
From the time/date of initiation of study treatment through 30 days following cessation of study treatment (regardless of treatment duration), or for duration of study treatment until initiation of other anticancer therapy, whichever occurred first, up to 51 months

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