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NCT02863991 · ADVERSE EVENTS

Adverse events

Oral ONC201 in Relapsed/Refractory Multiple Myeloma · Source last updated 2024-07-03

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 start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: 375 mg ONC201 + 20 mg Dexamethasone

Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.

0 / 22 / 20 / 2
Phase 2: 625 mg ONC201 + 20 mg Dexamethasone

Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.

5 / 1515 / 153 / 15

Group identifiers: EG000: Phase 1: 375 mg ONC201 + 20 mg Dexamethasone · EG001: Phase 2: 625 mg ONC201 + 20 mg Dexamethasone

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
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Disease progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Abscess limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Arthritis bacterial
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypoxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Pulmonary embolism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypercalcaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Cellulitis

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
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      15
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      15
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      15
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Vision blurred
  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
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Abdominal distention
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    term
    Constipation
  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
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Gastrointestinal haemorrhage
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants received 375 mg ONC201 once weekly in combination with 20 mg dexamethasone.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Phase 1: 375 mg ONC201 + 20 mg Dexamethasone
  2. deaths Num Affected
    3
    deaths Num At Risk
    15
    description
    Participants received 625 mg ONC201 once weekly in combination with 20 mg dexamethasone.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    5
    serious Num At Risk
    15
    title
    Phase 2: 625 mg ONC201 + 20 mg Dexamethasone
frequency Threshold
0
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
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      15
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      15
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      15
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      15
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Vision blurred
  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
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Abdominal distention
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
    term
    Constipation
  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
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Gastrointestinal haemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Disease progression
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Abscess limb
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Arthritis bacterial
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypoxia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Pulmonary embolism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypercalcaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Bone pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Cellulitis
time Frame
From the start date and time of the first dose of study treatment up to 30 calendar days after the last dose of study treatment, up to a maximum of 7 months.

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