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NCT01101880 · ADVERSE EVENTS

Adverse events

Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm · Source last updated 2017-10-19

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
Not reported
Other-event reporting threshold
0%

Other \[Not including Serious\] Adverse Events were not monitored/assessed.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Chemotherapy and Colony Stimulating Factor)

INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV

50 / 500 / 0Not reported / Not reported

Group identifiers: EG000: Treatment (Chemotherapy and Colony Stimulating Factor)

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      50
      num Events
      95
    term
    infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      50
      num Events
      31
    term
    Pulmonary
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      50
      num Events
      20
    term
    Liver enzymes
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      50
      num Events
      10
    term
    Gastrointestinal
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      50
      num Events
      10
    term
    Metabolic
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      50
      num Events
      10
    term
    Dermatologic
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
      num Events
      6
    term
    Neurologic
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      50
      num Events
      4
    term
    Coagulation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    term
    Cardiovascular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Ocular
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Hepatobiliary

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Complete source fields
    description
    Other \[Not including Serious\] Adverse Events were not monitored/assessed.
    event Groups
    1. description
      INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      50
      serious Num At Risk
      50
      title
      Treatment (Chemotherapy and Colony Stimulating Factor)
    frequency Threshold
    0
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        50
        num At Risk
        50
        num Events
        95
      term
      infection
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        31
        num At Risk
        50
        num Events
        31
      term
      Pulmonary
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      stats
      1. group Id
        EG000
        num Affected
        20
        num At Risk
        50
        num Events
        20
      term
      Liver enzymes
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        50
        num Events
        10
      term
      Gastrointestinal
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        50
        num Events
        10
      term
      Metabolic
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        50
        num Events
        10
      term
      Dermatologic
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        50
        num Events
        6
      term
      Neurologic
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        50
        num Events
        4
      term
      Coagulation
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        50
        num Events
        2
      term
      Cardiovascular
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        50
        num Events
        1
      term
      Ocular
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        50
        num Events
        1
      term
      Pain
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Hepatobiliary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        50
        num Events
        1
      term
      Hepatobiliary

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice