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NCT05656248 · OUTCOME

Toxicity Profile of Patients With SMN Treated With One or Two Courses of CPX-351

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Adverse events will be monitored from the time of first study intervention or treatment until 30 days after off-therapy.

What was measured

We will define categories for toxicity events and for each category we will determine the highest grade experienced by each patient. We will then report the number of patients with each grade in each category.

Analysis population: All 25 eligible patients.

Groups in this outcome

Grade 2 Toxicity

Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 2 toxicity

Grade 3 Toxicity

Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 3 toxicity

Grade 4 Toxicity

Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 4 toxicity

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Grade 2 Toxicity25
Grade 3 Toxicity25
Grade 4 Toxicity25

Reported measurements

Blood and lymphatic system disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity18Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Cardiac disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Eye disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity2Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Gastrointestinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity6Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity5Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
General disorders and administration site conditions
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity5Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity2Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity1Not reportedNot reportedNot reportedNot reported
Infections and infestations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity4Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity11Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity1Not reportedNot reportedNot reportedNot reported
Injury, poisoning and procedural complications
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity2Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity0Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Investigations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity1Not reportedNot reportedNot reportedNot reported
Musculoskeletal and connective tissue disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity2Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Nervous system disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Respiratory, thoracic and mediastinal disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity0Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity2Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity1Not reportedNot reportedNot reportedNot reported
Skin and subcutaneous tissue disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity9Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity1Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Vascular disorders
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Grade 2 Toxicity3Not reportedNot reportedNot reportedNot reported
Grade 3 Toxicity0Not reportedNot reportedNot reportedNot reported
Grade 4 Toxicity0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        0
    title
    Blood and lymphatic system disorders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Cardiac disorders
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Eye disorders
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
    title
    Gastrointestinal disorders
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    General disorders and administration site conditions
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        1
    title
    Infections and infestations
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Injury, poisoning and procedural complications
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Investigations
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Musculoskeletal and connective tissue disorders
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Nervous system disorders
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        1
    title
    Respiratory, thoracic and mediastinal disorders
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Skin and subcutaneous tissue disorders
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      25
    units
    Participants
description
We will define categories for toxicity events and for each category we will determine the highest grade experienced by each patient. We will then report the number of patients with each grade in each category.
groups
  1. description
    Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 2 toxicity
    id
    OG000
    title
    Grade 2 Toxicity
  2. description
    Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 3 toxicity
    id
    OG001
    title
    Grade 3 Toxicity
  3. description
    Patients with SMN treated with up to 2 courses of CPX-351 who developed grade 4 toxicity
    id
    OG002
    title
    Grade 4 Toxicity
param Type
NUMBER
population Description
All 25 eligible patients.
reporting Status
POSTED
time Frame
Adverse events will be monitored from the time of first study intervention or treatment until 30 days after off-therapy.
title
Toxicity Profile of Patients With SMN Treated With One or Two Courses of CPX-351
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice