0 Avaliações

ID

14566

Descrição

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01835288

Link

https://clinicaltrials.gov/show/NCT01835288

Palavras-chave

  1. 21/04/2016 21/04/2016 -
Transferido a

21 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0

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    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
    Descrição

    aml

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
    Descrição

    relapsed and/or refractory aml

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2367456
    eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
    Descrição

    eastern cooperative oncology group (ecog) performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    serum creatinine =< 2.0 mg/dl
    Descrição

    serum creatinine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    bilirubin =< 2.0 mg/dl
    Descrição

    bilirubin

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
    Descrição

    alanine aminotransferase

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    ability to understand and the willingness to sign a written informed consent document
    Descrição

    informed consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
    Descrição

    pregnant or breast-feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3242212
    patients who are currently receiving another investigational drug
    Descrição

    investigational drug

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    patients who are currently receiving other anti-cancer agents
    Descrição

    anti-cancer agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0003392
    uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
    Descrição

    infection

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3714514
    known hypersensitivity to arsenic trioxide
    Descrição

    hypersensitivity to arsenic trioxide

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0052416

    Similar models

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01835288

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    aml
    Item
    aml, any french- american- british (fab) subtype except m3, with confirmed mutation in the npm1 gene
    boolean
    C0023467 (UMLS CUI [1])
    relapsed and/or refractory aml
    Item
    relapsed and/or refractory aml from any duration of complete remission (cr); any number of prior therapies allowed
    boolean
    C2367456 (UMLS CUI [1])
    eastern cooperative oncology group (ecog) performance status
    Item
    eastern cooperative oncology group (ecog) performance status 0-2, life expectancy > 3 months
    boolean
    C1520224 (UMLS CUI [1])
    serum creatinine
    Item
    serum creatinine =< 2.0 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    bilirubin
    Item
    bilirubin =< 2.0 mg/dl
    boolean
    C1278039 (UMLS CUI [1])
    alanine aminotransferase
    Item
    alanine aminotransferase (alt)/aspartate aminotransferase (ast) =< 3 x upper limit of normal (uln)
    boolean
    C0201836 (UMLS CUI [1])
    informed consent
    Item
    ability to understand and the willingness to sign a written informed consent document
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnant or breast-feeding
    Item
    pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in women; sexually active males or females may not participate unless they have agreed to use an effective contraceptive method
    boolean
    C3242212 (UMLS CUI [1])
    investigational drug
    Item
    patients who are currently receiving another investigational drug
    boolean
    C0013230 (UMLS CUI [1])
    anti-cancer agents
    Item
    patients who are currently receiving other anti-cancer agents
    boolean
    C0003392 (UMLS CUI [1])
    infection
    Item
    uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
    boolean
    C3714514 (UMLS CUI [1])
    hypersensitivity to arsenic trioxide
    Item
    known hypersensitivity to arsenic trioxide
    boolean
    C0020517 (UMLS CUI [1,1])
    C0052416 (UMLS CUI [1,2])

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