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NCT00788125 · ADVERSE EVENTS

Adverse events

Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors · Source last updated 2023-07-14

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 were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Period 1: 35 mg/m^2 Dasatinib BID PO

35mg/m\^2/dose BID PO Dasatinib x 17 days Iphosfamide, Carboplatin, Etoposide microarray analysis western blotting immunohistochemistry staining method laboratory biomarker analysis therapeutic conventional surgery radiation therapy

6 / 77 / 76 / 7

Group identifiers: EG000: Period 1: 35 mg/m^2 Dasatinib BID PO

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
    notes
    Grade 5 Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils(ANC\<1.0 x 10e9/L) -- Brain (encephalitis, infections) Possibly, probably, or definitely attributable to the study regimen.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Infection -- Brain (encephalitis, infections)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Attribution is: Unlikely or unrelated to the study regimen.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    term
    Death not associated with CTCAE term -- Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Attributed is: Unlikely or unrelated to the study regimen.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    term
    Death not associated with CTCAE term -- Disease progression, NOS

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
    Immune system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    term
    Allergic reaction/hypersnsitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Leukocytes (total WBC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    term
    Supraventricular and nodal arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Vasovagal episode
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Left ventricular systolic dysfunction
Complete source fields
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    7
    description
    35mg/m\^2/dose BID PO Dasatinib x 17 days Iphosfamide, Carboplatin, Etoposide microarray analysis western blotting immunohistochemistry staining method laboratory biomarker analysis therapeutic conventional surgery radiation therapy
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Period 1: 35 mg/m^2 Dasatinib BID PO
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    term
    Allergic reaction/hypersnsitivity (including drug fever)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Leukocytes (total WBC)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Neutrophils/granulocytes (ANC/AGC)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      7
    term
    Platelets
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Palpitations
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    term
    Supraventricular and nodal arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Vasovagal episode
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Left ventricular systolic dysfunction
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5 Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils(ANC\<1.0 x 10e9/L) -- Brain (encephalitis, infections) Possibly, probably, or definitely attributable to the study regimen.
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    term
    Infection -- Brain (encephalitis, infections)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Attribution is: Unlikely or unrelated to the study regimen.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      7
    term
    Death not associated with CTCAE term -- Death NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Attributed is: Unlikely or unrelated to the study regimen.
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA v10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    term
    Death not associated with CTCAE term -- Disease progression, NOS
time Frame
Adverse events were collected for twenty-eight days post-first administration of Dasatinib, plus 14 days, to equal 42 days of follow-up for toxicity. After two months of follow-up of a three-patient cohort, consideration would be made for escalating the dose level in the next cohort of three patients. If toxicity does not resolve to meet study parameters for re-treatment by day 42 of the course, the patient must be removed from the study.

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Preserved source evidence · Not medical advice