Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05656248 · ADVERSE EVENTS

Adverse events

Study of CPX-351 (VYXEOS) in Individuals < 22 Years With Secondary Myeloid Neoplasms · Source last updated 2026-10-15

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
Adverse events will be monitored from the time of first study intervention or treatment until 30 days after off-therapy. Participants will be monitored for survival up to 3 years from enrollment.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
CPX-351 (Vyxeos)

All eligible patients will receive up to 2 cycles of CPX-351 for remission induction.

20 / 2523 / 2511 / 25

Group identifiers: EG000: CPX-351 (Vyxeos)

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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      25
      num Events
      25
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Papilledema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Typhlitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    General disorders and administration site conditions
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
      num Events
      4
    term
    Infections and infestations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Lung Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Nervous system disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Syncope
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Pleural effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Rash maculo-papular

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
    Eye disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Eye disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      25
      num Events
      5
    term
    Mucositis oral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Gastrointestinal disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Typhlitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    General disorders and administration site conditions
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      25
      num Events
      6
    term
    Infections and infestations - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
      num Events
      4
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Herpes simplex reactivation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Papulopustular rash
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Infusion related reaction
Complete source fields
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    25
    description
    All eligible patients will receive up to 2 cycles of CPX-351 for remission induction.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    25
    serious Num Affected
    20
    serious Num At Risk
    25
    title
    CPX-351 (Vyxeos)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Eye disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      25
      num Events
      5
    term
    Mucositis oral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Gastrointestinal disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Typhlitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    General disorders and administration site conditions
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Fever
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      25
      num Events
      6
    term
    Infections and infestations - Other, specify
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
      num Events
      4
    term
    Skin infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Herpes simplex reactivation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Papulopustular rash
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Infusion related reaction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      25
      num Events
      25
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Papilledema
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Typhlitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    General disorders and administration site conditions
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      25
      num Events
      3
    term
    Fever
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      25
      num Events
      4
    term
    Infections and infestations - Other, specify
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Lung Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      2
    term
    Nervous system disorders - Other, specify
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Syncope
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      25
      num Events
      2
    term
    Respiratory failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Pleural effusion
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTCAE v5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      25
      num Events
      1
    term
    Rash maculo-papular
time Frame
Adverse events will be monitored from the time of first study intervention or treatment until 30 days after off-therapy. Participants will be monitored for survival up to 3 years from enrollment.

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice