ID

42118

Beskrivning

Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01405573

Länk

https://clinicaltrials.gov/show/NCT01405573

Nyckelord

  1. 2016-05-27 2016-05-27 -
  2. 2021-04-10 2021-04-10 - Ahmed Rafee, MD
Rättsinnehavare

folgt

Uppladdad den

10 april 2021

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
    Beskrivning

    hepatic cell carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2239176
    age >18 years
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
    Beskrivning

    locoregional hcc

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027643
    liver function classified as child-pugh class b
    Beskrivning

    child-pugh class b

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3831116
    ecog performance status < or = 2
    Beskrivning

    ecog

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of at least 2 months
    Beskrivning

    life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    adequate contraception for fertile male and female patients
    Beskrivning

    contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0420837
    signed informed consent
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior exposure to sorafenib or antiangiogenesis drugs
    Beskrivning

    sorafenib

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1516119
    UMLS CUI [2]
    C0596087
    concomitant diseases that contraindicate the use of sorafenib
    Beskrivning

    concomitant diseases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0150941
    gastro-intestinal bleeding in the previous 30 days
    Beskrivning

    gastro-intestinal bleeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0017181
    altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
    Beskrivning

    renal function, hemoglobin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    UMLS CUI [2]
    C0232804
    serious active infections (> grade 2 ctcae version 3.0)
    Beskrivning

    active infections

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
    Beskrivning

    congestive heart failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    patients who are unable or unwilling to participate in the study
    Beskrivning

    patients who are unable or unwilling to participate in the study

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    pregnant or lactating females
    Beskrivning

    pregnant or lactating females

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C2828358
    hepatic encephalopathy of any grade
    Beskrivning

    hepatic encephalopathy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019151

    Similar models

    Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    hepatic cell carcinoma
    Item
    patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
    boolean
    C2239176 (UMLS CUI [1])
    age
    Item
    age >18 years
    boolean
    C0001779 (UMLS CUI [1])
    locoregional hcc
    Item
    advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
    boolean
    C0027643 (UMLS CUI [1])
    child-pugh class b
    Item
    liver function classified as child-pugh class b
    boolean
    C3831116 (UMLS CUI [1])
    ecog
    Item
    ecog performance status < or = 2
    boolean
    C1520224 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of at least 2 months
    boolean
    C0023671 (UMLS CUI [1])
    contraception
    Item
    adequate contraception for fertile male and female patients
    boolean
    C0420837 (UMLS CUI [1])
    informed consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    sorafenib
    Item
    prior exposure to sorafenib or antiangiogenesis drugs
    boolean
    C1516119 (UMLS CUI [1])
    C0596087 (UMLS CUI [2])
    concomitant diseases
    Item
    concomitant diseases that contraindicate the use of sorafenib
    boolean
    C0150941 (UMLS CUI [1])
    gastro-intestinal bleeding
    Item
    gastro-intestinal bleeding in the previous 30 days
    boolean
    C0017181 (UMLS CUI [1])
    renal function, hemoglobin
    Item
    altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
    boolean
    C0518015 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    active infections
    Item
    serious active infections (> grade 2 ctcae version 3.0)
    boolean
    C0009450 (UMLS CUI [1])
    congestive heart failure
    Item
    congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
    boolean
    C0018802 (UMLS CUI [1])
    patients who are unable or unwilling to participate in the study
    Item
    patients who are unable or unwilling to participate in the study
    boolean
    C2348568 (UMLS CUI [1])
    pregnant or lactating females
    Item
    pregnant or lactating females
    boolean
    C0549206 (UMLS CUI [1])
    C2828358 (UMLS CUI [2])
    hepatic encephalopathy
    Item
    hepatic encephalopathy of any grade
    boolean
    C0019151 (UMLS CUI [1])

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