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ID

15596

Descrizione

Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00050674

collegamento

https://clinicaltrials.gov/show/NCT00050674

Keywords

  1. 04/06/16 04/06/16 -
Caricato su

4 giugno 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Non-small Cell Lung Cancer NCT00050674

    Eligibility Non-small Cell Lung Cancer NCT00050674

    Criteria
    Descrizione

    Criteria

    subjects must have stage iv or iiib nsclc
    Descrizione

    nsclc

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0007131
    0-1 prior treatment regimens of chemotherapy
    Descrizione

    regimens of chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C0449788
    subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
    Descrizione

    measurable disease or evaluable disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1516986
    age > 18 years
    Descrizione

    age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    1st line - ecog 0-2
    Descrizione

    ecog

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    2nd line - ecog 0-1
    Descrizione

    ecog 2nd line

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
    Descrizione

    absolute neutrophil count

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    platelet count > or = 100 x 10 to the 9th power/l
    Descrizione

    platelet count

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005821
    adequate renal function with screening serum creatinine < or = 2.0 mg/dl
    Descrizione

    renal function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
    Descrizione

    adequate ast and alt

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C1278039
    subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
    Descrizione

    time between major surgery

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0872291
    UMLS CUI [1,2]
    C0087111
    negative hcg by urine or blood test in subject of child-bearing potential
    Descrizione

    negative hcg

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1141639
    UMLS CUI [1,2]
    C0205160
    life expectancy > 2 months
    Descrizione

    life expectancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
    Descrizione

    informed consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0021430

    Similar models

    Eligibility Non-small Cell Lung Cancer NCT00050674

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    nsclc
    Item
    subjects must have stage iv or iiib nsclc
    boolean
    C0007131 (UMLS CUI [1])
    regimens of chemotherapy
    Item
    0-1 prior treatment regimens of chemotherapy
    boolean
    C0392920 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    measurable disease or evaluable disease
    Item
    subjects must have bi-dimensionally measurable disease or evaluable disease by physical exam or radiological studies
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    age
    Item
    age > 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ecog
    Item
    1st line - ecog 0-2
    boolean
    C1520224 (UMLS CUI [1])
    ecog 2nd line
    Item
    2nd line - ecog 0-1
    boolean
    C1520224 (UMLS CUI [1])
    absolute neutrophil count
    Item
    absolute neutrophil count > or = 1.5 x 10 to the 9th power/l
    boolean
    C0948762 (UMLS CUI [1])
    platelet count
    Item
    platelet count > or = 100 x 10 to the 9th power/l
    boolean
    C0005821 (UMLS CUI [1])
    renal function
    Item
    adequate renal function with screening serum creatinine < or = 2.0 mg/dl
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    adequate ast and alt
    Item
    adequate ast and alt no more than 1.5 x the upper limit of normal and serum bilirubin < or = upper limit of normal
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    time between major surgery
    Item
    subjects must be at least two weeks from prior major thoracic or abdominal surgery and at least two weeks from completion of radiation therapy, and recovered from all toxicities associated with these treatments
    boolean
    C0872291 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    negative hcg
    Item
    negative hcg by urine or blood test in subject of child-bearing potential
    boolean
    C1141639 (UMLS CUI [1,1])
    C0205160 (UMLS CUI [1,2])
    life expectancy
    Item
    life expectancy > 2 months
    boolean
    C0023671 (UMLS CUI [1])
    informed consent
    Item
    ethical - before any study specific procedure is done or before study medication is administered, the subject or legally acceptable representative must give informed consent for participation in the study
    boolean
    C0021430 (UMLS CUI [1])

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