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ID

32411

Beschrijving

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

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Versies (1)
  1. 31-10-18 31-10-18 -
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GlaxoSmithKline

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31 oktober 2018

DOI

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Creative Commons BY-NC 3.0
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    Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

    Engels

    Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy

    1 Formulieren  
    PGx- Pharmacogenetic Research Consent
    Beschrijving

    PGx- Pharmacogenetic Research Consent

    Alias
    UMLS CUI-1
    C0021430
    UMLS CUI-2
    C2347500
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    Beschrijving

    Informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    If informed consent has been contained, record Date informed consent obtained for PGx- Pharmacogenetic research.
    Beschrijving

    Date informed consent obtained

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0011008
    If informed consent has been contained, has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
    Beschrijving

    Has a blood sample been collected for PGx- pharmacogenetic (DNA) research?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [2,1]
    C0005834
    UMLS CUI [2,2]
    C0031325
    UMLS CUI [2,3]
    C0035168
    If a blood sample has been collected for PGx- pharmacogenetic research, record date sample taken.
    Beschrijving

    Date sample taken

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C0035168
    UMLS CUI [1,3]
    C1302413
    If informed consent has not been obtained, check reason.
    Beschrijving

    Reason for informed consent has not been obtained

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0566251
    If other reason for informed consent not been obtained, specify.
    Beschrijving

    Other reason for informed consent not been obtained

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C2347500
    UMLS CUI [1,3]
    C0566251
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Pharmacogenetic (PGx) Research withdrawal of consent
    Beschrijving

    Pharmacogenetic (PGx) Research withdrawal of consent

    Alias
    UMLS CUI-1
    C0031325
    UMLS CUI-2
    C1707492
    Has subject withdrawn consent for PGx research?
    Beschrijving

    Has subject withdrawn consent for PGx research?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C1707492
    If subject has withdrawn consent, record date.
    Beschrijving

    Date informed consent withdrawn

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031325
    UMLS CUI [1,2]
    C1707492
    UMLS CUI [1,3]
    C0011008
    Has a request been made for sample destruction?
    Beschrijving

    Has a request been made for sample destruction?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    If a request has been made for sample destruction, check reason.
    Beschrijving

    Reason for request for sample destruction

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [1,4]
    C0566251
    If other reason for request for sample destruction, specify.
    Beschrijving

    Other reason for request for sample destruction

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1948029
    UMLS CUI [1,3]
    C0178913
    UMLS CUI [2,1]
    C0566251
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Liver Events
    Beschrijving

    Liver Events

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    Is this liver event a serious adverse event?
    Beschrijving

    Is this liver event a serious adverse event?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C1519255
    Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
    Beschrijving

    Liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0232741
    UMLS CUI [1,2]
    C0008000
    UMLS CUI [1,3]
    C0587081
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C2133636
    Is the subject age 55 or older?
    Beschrijving

    Is the subject age 55 or older?

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    If female, is the subject pregnant?
    Beschrijving

    If yes, ensure Pregnancy Notification Form has been completed.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0032961
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic reasonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    Beschrijving

    Diagnostic imaging tests of the liver or hepatobiliary system

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1711359
    UMLS CUI [1,3]
    C0023884
    UMLS CUI [2]
    C0412534
    UMLS CUI [3]
    C0040405
    UMLS CUI [4]
    C0412620
    UMLS CUI [5]
    C0024485
    UMLS CUI [6]
    C0008310
    If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
    Beschrijving

    If No, record the details on the Imaging form. Please ensure the overall diagnosis indicated by imaging is captured on the Non- serious Adverse Event form or serious Adverse Event form.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1711359
    UMLS CUI [1,3]
    C0023884
    UMLS CUI [1,4]
    C1274040
    Were any liver biopsies performed?
    Beschrijving

    If yes, complete Liver Biopsy form.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0193388
    Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
    Beschrijving

    If yes, record on the appropriate Concomitant Medication form.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1504473
    UMLS CUI [2]
    C0002346
    UMLS CUI [3]
    C0242295
    UMLS CUI [4]
    C0281875
    Did the subject fast or undergo significant dietary change in the past week?
    Beschrijving

    Did the subject fast or undergo significant change in the past week?

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    UMLS CUI [2,1]
    C3671772
    UMLS CUI [2,2]
    C0750502
    Investigational Product (Liver)
    Beschrijving

    Investigational Product (Liver)

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0023884
    When did the liver event occur?
    Beschrijving

    When did the liver event occur?

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0877248
    UMLS CUI [1,3]
    C2745955
    If the liver event occured during treatment period record start date of investigational product for that treatment period.
    Beschrijving

    If liver event occured after treatment period, start date of investigational product

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C2745955
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0808070
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1948053
    If the liver event occured during treatment period record stop date of investigational product for that treatment period.
    Beschrijving

    If liver event occured during treatment period, stop date of investigational product

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C2745955
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0806020
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1948053
    If the liver event occured after treatment period record start date of investigational product for the most recent period prior to the liver event.
    Beschrijving

    If liver event occured after treatment period, start date of investigational product

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C2745955
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0808070
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1948053
    If the liver event occured after treatment period record stop date of investigational product for the most recent period prior to the liver event.
    Beschrijving

    If liver event occured after treatment period, stop date of investigational product

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C2745955
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C0806020
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C1948053
    Pharmacokinetics (Liver)
    Beschrijving

    Pharmacokinetics (Liver)

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C0023884
    Was a pharmacokinetic blood sample obtained?
    Beschrijving

    Was a pharmacokinetic blood sample obtained?

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    If a pharmacokinetic blood sample was obtained, record date and time sample taken.
    Beschrijving

    Date and time sample taken

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C1264639
    If pharmacokinetic blood sample was obtained, record date and time of last investigational product dose prior to PK sample.
    Beschrijving

    Date and time of last investigational product dose prior to PK sample

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C1762893
    UMLS CUI [1,3]
    C0946444
    If pharmacokinetic blood sample was obtained, record date and time of last Ketoconazole dose prior to PK sample.
    Beschrijving

    Date and time of last Ketoconazole dose

    Datatype

    datetime

    Alias
    UMLS CUI [1,1]
    C0022625
    UMLS CUI [1,2]
    C1762893
    UMLS CUI [1,3]
    C0946444
    Medical conditions at onset of liver event
    Beschrijving

    Medical conditions at onset of liver event

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0332162
    UMLS CUI-3
    C0877248
    UMLS CUI-4
    C0023884
    Acute Viral Hepatitis A
    Beschrijving

    Acute Viral Hepatitis A

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0276434
    Chronic Hepatitis B
    Beschrijving

    Chronic Hepatitis B

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0524909
    Chronic Hepatitis C
    Beschrijving

    Chronic Hepatitis C

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0524910
    Cytomegalovirus Hepatitis
    Beschrijving

    Cytomegalovirus Hepatitis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0276252
    Epstein Barr Virus Infectious Mononucleosis
    Beschrijving

    Epstein Barr Virus Infectious Mononucleosis

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0021345
    UMLS CUI [1,2]
    C0014644
    Herpes Simplex Hepatitis
    Beschrijving

    Herpes Simplex Hepatitis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1963747
    Alcoholic Liver Disease
    Beschrijving

    Alcoholic Liver Disease

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0023896
    Non- alcoholic Steatohepatitis
    Beschrijving

    Non- alcoholic Steatohepatitis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3241937
    Fatty Liver
    Beschrijving

    Fatty Liver

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0015695
    Hepatic Cirrhosis
    Beschrijving

    Hepatic Cirrhosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0023890
    Hemochromatosis
    Beschrijving

    Hemochromatosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0018995
    Autoimmune Hepatitis
    Beschrijving

    Autoimmune Hepatitis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0241910
    Gallbladder disease
    Beschrijving

    Gallbladder disease

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0016977
    Drug related liver disease
    Beschrijving

    Drug related liver disease

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0277579
    Other Liver Disease Conditions
    Beschrijving

    Other Liver Disease Conditions

    Alias
    UMLS CUI-1
    C0023895
    UMLS CUI-2
    C0205394
    Sequence Number
    Beschrijving

    Sequence Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348184
    Specific Condition
    Beschrijving

    Specific Condition

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Status of liver disease condition
    Beschrijving

    Status of liver disease condition

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0449438
    Other medical conditions
    Beschrijving

    Other medical conditions

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0205394
    Drug Allergies
    Beschrijving

    Drug Allergies

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013227
    Rheumatoid Arthritis
    Beschrijving

    Rheumatoid Arthritis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0003873
    Psoriasis
    Beschrijving

    Psoriasis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0033860
    Thyroid Disease
    Beschrijving

    Thyroid Disease

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0040128
    Inflammatory Bowel Disease
    Beschrijving

    Inflammatory Bowel Disease

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0021390
    Lupus
    Beschrijving

    Lupus

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0409974
    Sjogren's Syndrome
    Beschrijving

    Sjogren's Syndrome

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1527336
    Vitiligo
    Beschrijving

    Vitiligo

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0042900
    Alcohol intake at onset of liver event
    Beschrijving

    Alcohol intake at onset of liver event

    Alias
    UMLS CUI-1
    C0001948
    UMLS CUI-2
    C0023884
    UMLS CUI-3
    C0877248
    UMLS CUI-4
    C0332162
    Does the subject consume alcohol?
    Beschrijving

    Does the subject consume alcohol?

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001948
    If subject consumes alcohol, record the average number of units of alcohol consumed per week.
    Beschrijving

    Average number of units of alcohol consumed per week

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0001948
    UMLS CUI [1,2]
    C0560579
    Liver imaging
    Beschrijving

    Liver imaging

    Alias
    UMLS CUI-1
    C2711860
    Date of hepatic or liver imaging test.
    Beschrijving

    Date of hepatic or liver imaging tes

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C0011008
    What method was used for this imaging test?
    Beschrijving

    Method used for this imaging test

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C1275506
    If other method was used for imaging test, specify.
    Beschrijving

    Other method used for imaging test

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2711860
    UMLS CUI [1,2]
    C1275506
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Are images technically adequate?
    Beschrijving

    Are images technically adequate?

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0806487
    If other image quality, specify.
    Beschrijving

    Other image quality

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0806487
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Indicate the liver size
    Beschrijving

    Indicate the liver size

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0426688
    If other liver size, specify.
    Beschrijving

    Other liver size

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0426688
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Indicate the liver texture.
    Beschrijving

    Indicate the liver texture.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0679033
    UMLS CUI [1,2]
    C0023884
    If other liver texture, specify.
    Beschrijving

    Other liver texture

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0679033
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [1,4]
    C0205394
    Grade the diffuse and/ or geographic fatty infiltrate of the liver
    Beschrijving

    Grade the diffuse and/ or geographic fatty infiltrate of the liver

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0015695
    UMLS CUI [1,2]
    C0205219
    UMLS CUI [2,1]
    C0015695
    UMLS CUI [2,2]
    C1517526
    If other fatty infiltrate of the liver, specify.
    Beschrijving

    Other fatty infiltrate of the liver

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0015695
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Ascites present
    Beschrijving

    Ascites present

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0003962
    If other ascites, specify.
    Beschrijving

    Other ascites

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0003962
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Are focal hepatic lesions characterisable?
    Beschrijving

    Focal hepatic lesions

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    If other focal hepatic lesions, specify.
    Beschrijving

    Other focal hepatic lesions

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Gallstones or gallbladder lesions?
    Beschrijving

    Gallstones or gallbladder lesions?

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C3842395
    UMLS CUI [1,2]
    C0221198
    If other gallstones or gallbladder lesions, specify.
    Beschrijving

    Other gallstones or gallbladder lesions

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3842395
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Biliary ductal lesions?
    Beschrijving

    Biliary ductal lesions?

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    If other biliary ductal lesions, specify.
    Beschrijving

    Other biliary ductal lesions

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C2348235
    UMLS CUI [1,4]
    C0205394
    Portal/ Hepatic vein abnormalities?
    Beschrijving

    Portal/ Hepatic vein abnormalities?

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [2,1]
    C0032718
    UMLS CUI [2,2]
    C1704258
    If other portal/ hepatic vein abnormalities, specify.
    Beschrijving

    Other portal/ hepatic vein abnormalities

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0032718
    UMLS CUI [2,2]
    C1704258
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [2,4]
    C2348235
    Liver biopsy
    Beschrijving

    Liver biopsy

    Alias
    UMLS CUI-1
    C0193388
    Date of liver biopsy
    Beschrijving

    Date of liver biopsy

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0193388
    UMLS CUI [1,2]
    C0011008
    Approximate size of liver biopsy
    Beschrijving

    Approximate size of liver biopsy

    Datatype

    float

    Maateenheden
    • mm
    Alias
    UMLS CUI [1,1]
    C1299482
    UMLS CUI [1,2]
    C0193388
    mm
    Final Diagnosis
    Beschrijving

    Final Diagnosis

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1546485
    If other final diagnosis, specify.
    Beschrijving

    Other final diagnosis

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1546485
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Liver Architecture
    Beschrijving

    Liver Architecture

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0935919
    If other liver architecture, specify.
    Beschrijving

    Other liver architecture.

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0935919
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Description of liver cells or hepatocytes
    Beschrijving

    Description of liver cells or hepatocytes

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C0678257
    If other description of liver cells or hepatocytes, specify.
    Beschrijving

    Other description of liver cells or hepatocytes

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Liver cell or hepatocyte inclusions or vacuoles
    Beschrijving

    Liver cell or hepatocyte inclusions or vacuoles

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C0042219
    UMLS CUI [1,3]
    C1512693
    If other liver cell or hepatocyte inclusions or vacuoles, specify.
    Beschrijving

    Other liver cell or hepatocyte inclusions or vacuoles

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C0042219
    UMLS CUI [1,3]
    C1512693
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Hepatocyte or liver cell nuclear abnormalities.
    Beschrijving

    Hepatocyte or liver cell nuclear abnormalities.

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C1849376
    If other hepatocyte or liver cell nuclear abnormalities, specify.
    Beschrijving

    Other hepatocyte or liver cell nuclear abnormalities

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C1849376
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Liver or lobular infiltrates
    Beschrijving

    Liver or lobular infiltrates

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1400896
    UMLS CUI [1,2]
    C0205417
    If other liver or lobular infiltrates, specify.
    Beschrijving

    Other liver or lobular infiltrates

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1400896
    UMLS CUI [1,2]
    C0205417
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Portal tract inflammation
    Beschrijving

    Portal tract inflammation

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C3854488
    If other portal tract inflammation, specify.
    Beschrijving

    Other portal tract inflammation

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C3854488
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Bile ducts
    Beschrijving

    Bile ducts

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0005400
    If other bile ducts, specify.
    Beschrijving

    Other bile ducts

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0005400
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Portal veins
    Beschrijving

    Portal veins

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0032718
    If other portal vein structure, specify.
    Beschrijving

    Other portal vein structure

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0032718
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Liver infections
    Beschrijving

    Liver infections

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1112211
    If other liver infections, specify.
    Beschrijving

    Other liver infections

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1112211
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Parasites or Ova
    Beschrijving

    Parasites or Ova

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0030498
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0555117
    If other parasites or ova, specify.
    Beschrijving

    Other parasites or ova

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0030498
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0555117
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Histologic staining or additional studies obtained
    Beschrijving

    Histologic staining or additional studies obtained

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0487602
    UMLS CUI [1,2]
    C0205462
    UMLS CUI [2,1]
    C2603343
    UMLS CUI [2,2]
    C1524062
    If other histologic staining or additional studies obtained,l specify.
    Beschrijving

    Other histologic staining or additional studies

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0487602
    UMLS CUI [1,2]
    C0205462
    UMLS CUI [2,1]
    C2603343
    UMLS CUI [2,2]
    C1524062
    UMLS CUI [3,1]
    C0205394
    UMLS CUI [3,2]
    C2348235
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    Similar models

    Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    PGx- Pharmacogenetic Research Consent
    C0021430 (UMLS CUI-1)
    C2347500 (UMLS CUI-2)
    Informed consent
    Item
    Has informed consent been obtained for PGx- Pharmacogenetic research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    Date informed consent obtained
    Item
    If informed consent has been contained, record Date informed consent obtained for PGx- Pharmacogenetic research.
    date
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
    Item
    If informed consent has been contained, has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
    boolean
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0005834 (UMLS CUI [2,1])
    C0031325 (UMLS CUI [2,2])
    C0035168 (UMLS CUI [2,3])
    Date sample taken
    Item
    If a blood sample has been collected for PGx- pharmacogenetic research, record date sample taken.
    date
    C0031325 (UMLS CUI [1,1])
    C0035168 (UMLS CUI [1,2])
    C1302413 (UMLS CUI [1,3])
    Item
    If informed consent has not been obtained, check reason.
    integer
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    undefined item
    Code List
    If informed consent has not been obtained, check reason.
    CL Item
    Subject declined (1)
    CL Item
    Subject not asked by investigator (2)
    CL Item
    Other, specify (3)
    Other reason for informed consent not been obtained
    Item
    If other reason for informed consent not been obtained, specify.
    text
    C0021430 (UMLS CUI [1,1])
    C2347500 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item Group
    Pharmacogenetic (PGx) Research withdrawal of consent
    C0031325 (UMLS CUI-1)
    C1707492 (UMLS CUI-2)
    Has subject withdrawn consent for PGx research?
    Item
    Has subject withdrawn consent for PGx research?
    boolean
    C0031325 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    Date informed consent withdrawn
    Item
    If subject has withdrawn consent, record date.
    date
    C0031325 (UMLS CUI [1,1])
    C1707492 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Has a request been made for sample destruction?
    Item
    Has a request been made for sample destruction?
    boolean
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    Item
    If a request has been made for sample destruction, check reason.
    integer
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [1,4])
    Reason for request for sample destruction
    Code List
    If a request has been made for sample destruction, check reason.
    CL Item
    Subject withdrew consent for PGx (3)
    CL Item
    Screen failure (2)
    CL Item
    Other, specify (1)
    Other reason for request for sample destruction
    Item
    If other reason for request for sample destruction, specify.
    text
    C1272683 (UMLS CUI [1,1])
    C1948029 (UMLS CUI [1,2])
    C0178913 (UMLS CUI [1,3])
    C0566251 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item Group
    Liver Events
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Is this liver event a serious adverse event?
    Item
    Is this liver event a serious adverse event?
    boolean
    C0023884 (UMLS CUI [1,1])
    C1519255 (UMLS CUI [1,2])
    Item
    Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
    integer
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C2133636 (UMLS CUI [2,2])
    Liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria
    Code List
    Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
    CL Item
    ALT (alanine aminotansferase) (1)
    CL Item
    AST (aspartate aminotransferase) (2)
    CL Item
    Total bilirubin (3)
    CL Item
    Alkaline phosphatase (4)
    CL Item
    5' nucleotidase (5)
    CL Item
    Gammaglutamyltranspeptidase (6)
    CL Item
    Other (7)
    Is the subject age 55 or older?
    Item
    Is the subject age 55 or older?
    boolean
    C0001779 (UMLS CUI [1])
    Item
    If female, is the subject pregnant?
    text
    C0032961 (UMLS CUI [1])
    If female, is the subject pregnant?
    Code List
    If female, is the subject pregnant?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    CL Item
    Not applicable (X)
    Diagnostic imaging tests of the liver or hepatobiliary system
    Item
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic reasonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    boolean
    C0011923 (UMLS CUI [1,1])
    C1711359 (UMLS CUI [1,2])
    C0023884 (UMLS CUI [1,3])
    C0412534 (UMLS CUI [2])
    C0040405 (UMLS CUI [3])
    C0412620 (UMLS CUI [4])
    C0024485 (UMLS CUI [5])
    C0008310 (UMLS CUI [6])
    Diagnostic imaging tests of the liver or hepatobiliary system results
    Item
    If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
    boolean
    C0011923 (UMLS CUI [1,1])
    C1711359 (UMLS CUI [1,2])
    C0023884 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    Liver biopsies
    Item
    Were any liver biopsies performed?
    boolean
    C0193388 (UMLS CUI [1])
    Herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
    Item
    Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
    boolean
    C1504473 (UMLS CUI [1])
    C0002346 (UMLS CUI [2])
    C0242295 (UMLS CUI [3])
    C0281875 (UMLS CUI [4])
    Did the subject fast or undergo significant change in the past week?
    Item
    Did the subject fast or undergo significant dietary change in the past week?
    boolean
    C0015663 (UMLS CUI [1])
    C3671772 (UMLS CUI [2,1])
    C0750502 (UMLS CUI [2,2])
    Item Group
    Investigational Product (Liver)
    C0304229 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    Item
    When did the liver event occur?
    text
    C0023884 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    When did the liver event occur?
    Code List
    When did the liver event occur?
    CL Item
    During the treatment period: If the liver event occured during treatment period record start and stop date of investigational product for that treatment period. (D)
    CL Item
    After the treatment period: If the liver event occured after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. (A)
    If liver event occured after treatment period, start date of investigational product
    Item
    If the liver event occured during treatment period record start date of investigational product for that treatment period.
    date
    C0877248 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C1948053 (UMLS CUI [3,2])
    If liver event occured during treatment period, stop date of investigational product
    Item
    If the liver event occured during treatment period record stop date of investigational product for that treatment period.
    date
    C0877248 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C1948053 (UMLS CUI [3,2])
    If liver event occured after treatment period, start date of investigational product
    Item
    If the liver event occured after treatment period record start date of investigational product for the most recent period prior to the liver event.
    date
    C0877248 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0808070 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C1948053 (UMLS CUI [3,2])
    If liver event occured after treatment period, stop date of investigational product
    Item
    If the liver event occured after treatment period record stop date of investigational product for the most recent period prior to the liver event.
    date
    C0877248 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C2745955 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C0806020 (UMLS CUI [2,2])
    C0087111 (UMLS CUI [3,1])
    C1948053 (UMLS CUI [3,2])
    Item Group
    Pharmacokinetics (Liver)
    C0031327 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    Was a pharmacokinetic blood sample obtained?
    Item
    Was a pharmacokinetic blood sample obtained?
    boolean
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    Date and time sample taken
    Item
    If a pharmacokinetic blood sample was obtained, record date and time sample taken.
    datetime
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Date and time of last investigational product dose prior to PK sample
    Item
    If pharmacokinetic blood sample was obtained, record date and time of last investigational product dose prior to PK sample.
    datetime
    C0304229 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C0946444 (UMLS CUI [1,3])
    Date and time of last Ketoconazole dose
    Item
    If pharmacokinetic blood sample was obtained, record date and time of last Ketoconazole dose prior to PK sample.
    datetime
    C0022625 (UMLS CUI [1,1])
    C1762893 (UMLS CUI [1,2])
    C0946444 (UMLS CUI [1,3])
    Item Group
    Medical conditions at onset of liver event
    C0012634 (UMLS CUI-1)
    C0332162 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    C0023884 (UMLS CUI-4)
    Item
    Acute Viral Hepatitis A
    integer
    C0276434 (UMLS CUI [1])
    Acute Viral Hepatitis A
    Code List
    Acute Viral Hepatitis A
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Chronic Hepatitis B
    integer
    C0524909 (UMLS CUI [1])
    Chronic Hepatitis B
    Code List
    Chronic Hepatitis B
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Chronic Hepatitis C
    integer
    C0524910 (UMLS CUI [1])
    Chronic Hepatitis C
    Code List
    Chronic Hepatitis C
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Cytomegalovirus Hepatitis
    integer
    C0276252 (UMLS CUI [1])
    Cytomegalovirus Hepatitis
    Code List
    Cytomegalovirus Hepatitis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Epstein Barr Virus Infectious Mononucleosis
    integer
    C0021345 (UMLS CUI [1,1])
    C0014644 (UMLS CUI [1,2])
    Epstein Barr Virus Infectious Mononucleosis
    Code List
    Epstein Barr Virus Infectious Mononucleosis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Herpes Simplex Hepatitis
    integer
    C1963747 (UMLS CUI [1])
    Herpes Simplex Hepatitis
    Code List
    Herpes Simplex Hepatitis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Alcoholic Liver Disease
    integer
    C0023896 (UMLS CUI [1])
    Alcoholic Liver Disease
    Code List
    Alcoholic Liver Disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Non- alcoholic Steatohepatitis
    integer
    C3241937 (UMLS CUI [1])
    Non- alcoholic Steatohepatitis
    Code List
    Non- alcoholic Steatohepatitis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Fatty Liver
    integer
    C0015695 (UMLS CUI [1])
    Fatty Liver
    Code List
    Fatty Liver
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Hepatic Cirrhosis
    integer
    C0023890 (UMLS CUI [1])
    Hepatic Cirrhosis
    Code List
    Hepatic Cirrhosis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Hemochromatosis
    integer
    C0018995 (UMLS CUI [1])
    Hemochromatosis
    Code List
    Hemochromatosis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Autoimmune Hepatitis
    integer
    C0241910 (UMLS CUI [1])
    Autoimmune Hepatitis
    Code List
    Autoimmune Hepatitis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Gallbladder disease
    integer
    C0016977 (UMLS CUI [1])
    Gallbladder disease
    Code List
    Gallbladder disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Drug related liver disease
    integer
    C0023895 (UMLS CUI [1,1])
    C0277579 (UMLS CUI [1,2])
    Drug related liver disease
    Code List
    Drug related liver disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item Group
    Other Liver Disease Conditions
    C0023895 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Specific Condition
    Item
    Specific Condition
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Status of liver disease condition
    integer
    C0023895 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Status of liver disease condition
    Code List
    Status of liver disease condition
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item Group
    Other medical conditions
    C0012634 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Item
    Drug Allergies
    integer
    C0020517 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Drug Allergies
    Code List
    Drug Allergies
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Rheumatoid Arthritis
    integer
    C0003873 (UMLS CUI [1])
    Rheumatoid Arthritis
    Code List
    Rheumatoid Arthritis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Psoriasis
    integer
    C0033860 (UMLS CUI [1])
    Psoriasis
    Code List
    Psoriasis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Thyroid Disease
    integer
    C0040128 (UMLS CUI [1])
    Thyroid Disease
    Code List
    Thyroid Disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Inflammatory Bowel Disease
    integer
    C0021390 (UMLS CUI [1])
    Inflammatory Bowel Disease
    Code List
    Inflammatory Bowel Disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Lupus
    integer
    C0409974 (UMLS CUI [1])
    Lupus
    Code List
    Lupus
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Sjogren's Syndrome
    integer
    C1527336 (UMLS CUI [1])
    Sjogren's Syndrome
    Code List
    Sjogren's Syndrome
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item
    Vitiligo
    integer
    C0042900 (UMLS CUI [1])
    Vitiligo
    Code List
    Vitiligo
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (3)
    Item Group
    Alcohol intake at onset of liver event
    C0001948 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    C0332162 (UMLS CUI-4)
    Does the subject consume alcohol?
    Item
    Does the subject consume alcohol?
    boolean
    C0001948 (UMLS CUI [1])
    Average number of units of alcohol consumed per week
    Item
    If subject consumes alcohol, record the average number of units of alcohol consumed per week.
    integer
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    Liver imaging
    C2711860 (UMLS CUI-1)
    Date of hepatic or liver imaging tes
    Item
    Date of hepatic or liver imaging test.
    date
    C2711860 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    What method was used for this imaging test?
    integer
    C2711860 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    Method used for this imaging test
    Code List
    What method was used for this imaging test?
    CL Item
    Ultrasound - transabdominal (1)
    CL Item
    Ultrasound - endoscopic (2)
    CL Item
    Magnetic Resonance Imaging (MRI) (3)
    CL Item
    Computerised Tomography (CT) (4)
    CL Item
    Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
    CL Item
    Positron Emission Tomography (PET) (6)
    CL Item
    Positron Emission Tomography/ Computerised Tomography (PET/ CT) (7)
    CL Item
    Other, specify (8)
    Other method used for imaging test
    Item
    If other method was used for imaging test, specify.
    text
    C2711860 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Are images technically adequate?
    integer
    C0806487 (UMLS CUI [1])
    Are images technically adequate?
    Code List
    Are images technically adequate?
    CL Item
    Optimal (1)
    CL Item
    Readable, but not optimal (2)
    CL Item
    Not readable (3)
    CL Item
    Other, specify (4)
    Other image quality
    Item
    If other image quality, specify.
    text
    C0806487 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Indicate the liver size
    integer
    C0426688 (UMLS CUI [1])
    Indicate the liver size
    Code List
    Indicate the liver size
    CL Item
    Normal size (1)
    CL Item
    Hypertrophy (or enlarged) (2)
    CL Item
    Atrophy (or smaller than normal) (3)
    CL Item
    Segmental hypertrophy (4)
    CL Item
    Other, specify (5)
    Other liver size
    Item
    If other liver size, specify.
    text
    C0426688 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Indicate the liver texture.
    integer
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    Indicate the liver texture.
    Code List
    Indicate the liver texture.
    CL Item
    Normal (1)
    CL Item
    Heterogeneous (2)
    CL Item
    Suggestive of fibrosis (3)
    CL Item
    Nodular or suggestive of cirrhosis (4)
    CL Item
    Other, specify (5)
    Other liver texture
    Item
    If other liver texture, specify.
    text
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    Grade the diffuse and/ or geographic fatty infiltrate of the liver
    integer
    C0015695 (UMLS CUI [1,1])
    C0205219 (UMLS CUI [1,2])
    C0015695 (UMLS CUI [2,1])
    C1517526 (UMLS CUI [2,2])
    Grade the diffuse and/ or geographic fatty infiltrate of the liver
    Code List
    Grade the diffuse and/ or geographic fatty infiltrate of the liver
    CL Item
    Not applicable - no fatty infiltration (1)
    CL Item
    Mild (<= 25%) (2)
    CL Item
    Moderate (>25% to <75%) (3)
    CL Item
    Severe (>= 75%) (4)
    CL Item
    Other, specify (5)
    Other fatty infiltrate of the liver
    Item
    If other fatty infiltrate of the liver, specify.
    text
    C0015695 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Ascites present
    integer
    C0003962 (UMLS CUI [1])
    Ascites present
    Code List
    Ascites present
    CL Item
    Non present (1)
    CL Item
    Yes - small amount (2)
    CL Item
    Yes - moderate or severe amount (3)
    CL Item
    Other, specify (99)
    Other ascites
    Item
    If other ascites, specify.
    text
    C0003962 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Are focal hepatic lesions characterisable?
    integer
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    Focal hepatic lesions
    Code List
    Are focal hepatic lesions characterisable?
    CL Item
    Not applicable (1)
    CL Item
    Solid (2)
    CL Item
    Cystic (3)
    CL Item
    Hemangioma (4)
    CL Item
    Focal Nodular Hyperplasia (5)
    CL Item
    Other, specify (6)
    Other focal hepatic lesions
    Item
    If other focal hepatic lesions, specify.
    text
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Gallstones or gallbladder lesions?
    integer
    C3842395 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Gallstones or gallbladder lesions?
    Code List
    Gallstones or gallbladder lesions?
    CL Item
    None (1)
    CL Item
    Gallstones (2)
    CL Item
    Gallbladder polyp(s) (3)
    CL Item
    Sludge (4)
    CL Item
    Gallbladder wall thickening/ oedema (5)
    CL Item
    Gallbladder wall gas (6)
    CL Item
    Cholecystitis (7)
    CL Item
    Gallbladder wall calcification (8)
    CL Item
    Gallbladder mass (9)
    CL Item
    Other, specify (10)
    Other gallstones or gallbladder lesions
    Item
    If other gallstones or gallbladder lesions, specify.
    text
    C3842395 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Biliary ductal lesions?
    integer
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Biliary ductal lesions?
    Code List
    Biliary ductal lesions?
    CL Item
    None (1)
    CL Item
    Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
    CL Item
    Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
    CL Item
    Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
    CL Item
    Extrahepatic ductal dilation (5)
    CL Item
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ductus) (6)
    CL Item
    Acute Cholangitis (7)
    CL Item
    Primary sclerosing cholangitis (8)
    CL Item
    Choledocholithiasis (gallstone in duct) (9)
    CL Item
    Ducta filling defect(s), other than gallstone (10)
    CL Item
    Ductal wall thickening or oedema (11)
    CL Item
    Choledochal cyst (12)
    CL Item
    Ductal mass (13)
    CL Item
    Extrinsic mass compressing bile duct(s) (14)
    CL Item
    Other, specify (15)
    Other biliary ductal lesions
    Item
    If other biliary ductal lesions, specify.
    text
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item
    Portal/ Hepatic vein abnormalities?
    integer
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    Portal/ Hepatic vein abnormalities?
    Code List
    Portal/ Hepatic vein abnormalities?
    CL Item
    None (1)
    CL Item
    Portal vein enlargement (2)
    CL Item
    Hepatic vein enlargement (3)
    CL Item
    Non- occlusive portal vein thrombosis (4)
    CL Item
    Occlusvie portal vein thrombosis - bland (5)
    CL Item
    Hepatic vein thrombosis - bland (6)
    CL Item
    Occlusive portal vein thrombosis - malignant (7)
    CL Item
    Hepatic vein thrombosis - malignant (8)
    CL Item
    Involvement of the main portal vein (9)
    CL Item
    Involvement of the right portal vein (10)
    CL Item
    involvement of the left portal vein (11)
    CL Item
    Budd- Chiari syndrome (12)
    CL Item
    Other, specify (13)
    Other portal/ hepatic vein abnormalities
    Item
    If other portal/ hepatic vein abnormalities, specify.
    text
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0032718 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C2348235 (UMLS CUI [2,4])
    Item Group
    Liver biopsy
    C0193388 (UMLS CUI-1)
    Date of liver biopsy
    Item
    Date of liver biopsy
    date
    C0193388 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Approximate size of liver biopsy
    Item
    Approximate size of liver biopsy
    float
    C1299482 (UMLS CUI [1,1])
    C0193388 (UMLS CUI [1,2])
    Item
    Final Diagnosis
    integer
    C1546485 (UMLS CUI [1])
    Final Diagnosis
    Code List
    Final Diagnosis
    CL Item
    Normal (1)
    CL Item
    Acute hepatitis (2)
    CL Item
    Chronic hepatitis (3)
    CL Item
    Cholestatic hepatitis (4)
    CL Item
    Drug- induced cholestais (5)
    CL Item
    Acute viral hepatitis (6)
    CL Item
    Chronic viral hepatitis (7)
    CL Item
    Drug- induced hepatitis (8)
    CL Item
    Autoimmune hepatitis (9)
    CL Item
    Bridging necrosis (10)
    CL Item
    Submassive hepatic necrosis (11)
    CL Item
    Massive hepatic necrosis (12)
    CL Item
    Steatosis - microvesicular (13)
    CL Item
    Steatosis - macrovesicular (14)
    CL Item
    Steatosis - mixed (15)
    CL Item
    Non- alcoholic steatohepatitis (16)
    CL Item
    Alcoholic hepatitis (17)
    CL Item
    Hepatic granulomas (18)
    CL Item
    Sarcoidosis (19)
    CL Item
    Fibrosis (20)
    CL Item
    Cirrhosis (21)
    CL Item
    Primary biliary cirrhosis (22)
    CL Item
    Primary sclerosing cholangitis (23)
    CL Item
    Autoimmune overlap syndrome (24)
    CL Item
    Hemochromatosis (25)
    CL Item
    Alpha-1- antitrypsin deficiency (26)
    CL Item
    Wilson's disease (27)
    CL Item
    Veno- occlusive disease (28)
    CL Item
    Budd- Chiari syndrome (29)
    CL Item
    Neoplasia (30)
    CL Item
    Other (31)
    Other final diagnosis
    Item
    If other final diagnosis, specify.
    text
    C1546485 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Liver Architecture
    integer
    C0023884 (UMLS CUI [1,1])
    C0935919 (UMLS CUI [1,2])
    Liver Architecture
    Code List
    Liver Architecture
    CL Item
    Normal (1)
    CL Item
    Bridging fibrosis (2)
    CL Item
    Diffuse fibrosis (3)
    CL Item
    Nodular regenerative hyperplasia (4)
    CL Item
    Congenital hepatic fibrosis (5)
    CL Item
    Cirrhosis (6)
    CL Item
    Centrilobular congestion (7)
    CL Item
    Endophlebitis (8)
    CL Item
    Veno- occlusive disease (9)
    CL Item
    Canalicular cholestasis (10)
    CL Item
    Apoptosis (11)
    CL Item
    Focal (or spotty or mild) hepatocelular necrosis (12)
    CL Item
    Interface hepatitis (periportal hepatitis or pieceneal necrosis) (13)
    CL Item
    Ischaemic necrosis (14)
    CL Item
    Centrolobular (Zone 3) necrosis (15)
    CL Item
    Bridging hepatocellular necrosis (16)
    CL Item
    Massive or panlobular hepatocellular necrosis (17)
    CL Item
    Dysplasia (18)
    CL Item
    Neoplasia (19)
    CL Item
    Other (20)
    Other liver architecture.
    Item
    If other liver architecture, specify.
    text
    C0023884 (UMLS CUI [1,1])
    C0935919 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Description of liver cells or hepatocytes
    integer
    C0227525 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Description of liver cells or hepatocytes
    Code List
    Description of liver cells or hepatocytes
    CL Item
    Normal (1)
    CL Item
    Ballooning (2)
    CL Item
    Acidophilic (3)
    CL Item
    Pseudoxanthomatous (4)
    CL Item
    Multinucleated giant hepatocytes (5)
    CL Item
    Other, specify (6)
    Other description of liver cells or hepatocytes
    Item
    If other description of liver cells or hepatocytes, specify.
    text
    C0227525 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Liver cell or hepatocyte inclusions or vacuoles
    integer
    C0227525 (UMLS CUI [1,1])
    C0042219 (UMLS CUI [1,2])
    C1512693 (UMLS CUI [1,3])
    Liver cell or hepatocyte inclusions or vacuoles
    Code List
    Liver cell or hepatocyte inclusions or vacuoles
    CL Item
    No inclusions (1)
    CL Item
    Macrovesicular steatosis (2)
    CL Item
    Microvesicular steatosis (3)
    CL Item
    Bile accumulation (4)
    CL Item
    Diastase- resistant, PAS- positive cytoplasmic inclusions (5)
    CL Item
    Alpha-1- antitrypsin inclusions (6)
    CL Item
    Megamitochondria (7)
    CL Item
    Mallory bodies (8)
    CL Item
    "Ground Glass" inclusions (9)
    CL Item
    Lipofuscin pigment (10)
    CL Item
    Hemosiderin granules (11)
    CL Item
    Orcein- positive cytoplasmin granules (12)
    CL Item
    Protoporphyrin crystals (birefringent under polarised light) (13)
    CL Item
    Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
    CL Item
    Other, specify (15)
    Other liver cell or hepatocyte inclusions or vacuoles
    Item
    If other liver cell or hepatocyte inclusions or vacuoles, specify.
    text
    C0227525 (UMLS CUI [1,1])
    C0042219 (UMLS CUI [1,2])
    C1512693 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Hepatocyte or liver cell nuclear abnormalities.
    integer
    C0227525 (UMLS CUI [1,1])
    C1849376 (UMLS CUI [1,2])
    Hepatocyte or liver cell nuclear abnormalities.
    Code List
    Hepatocyte or liver cell nuclear abnormalities.
    CL Item
    None (1)
    CL Item
    Hepatocellular mitosis (2)
    CL Item
    Binucleated or multinucleated hepatocytes (3)
    CL Item
    CMV inclusion bodies (4)
    CL Item
    HSV inclusions (5)
    CL Item
    Varicella inclusions (6)
    CL Item
    Other, specify (7)
    Other hepatocyte or liver cell nuclear abnormalities
    Item
    If other hepatocyte or liver cell nuclear abnormalities, specify.
    text
    C0227525 (UMLS CUI [1,1])
    C1849376 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Liver or lobular infiltrates
    integer
    C1400896 (UMLS CUI [1,1])
    C0205417 (UMLS CUI [1,2])
    Liver or lobular infiltrates
    Code List
    Liver or lobular infiltrates
    CL Item
    None (1)
    CL Item
    Eosinophils (2)
    CL Item
    Lymphocytes (3)
    CL Item
    Plasma cells (4)
    CL Item
    Neutrophils (5)
    CL Item
    Macrophages and proliferating Kupffer cells (6)
    CL Item
    Granulomas (7)
    CL Item
    Other, specify (8)
    Other liver or lobular infiltrates
    Item
    If other liver or lobular infiltrates, specify.
    text
    C1400896 (UMLS CUI [1,1])
    C0205417 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Portal tract inflammation
    integer
    C3854488 (UMLS CUI [1])
    Portal tract inflammation
    Code List
    Portal tract inflammation
    CL Item
    None (1)
    CL Item
    Eosinophils (2)
    CL Item
    Lymphoid aggregates and/ or follicles (3)
    CL Item
    Plasma cells (4)
    CL Item
    Neutrophils (5)
    CL Item
    Histocytes and macrophages (6)
    CL Item
    Other (7)
    Other portal tract inflammation
    Item
    If other portal tract inflammation, specify.
    text
    C3854488 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Bile ducts
    integer
    C0005400 (UMLS CUI [1])
    Bile ducts
    Code List
    Bile ducts
    CL Item
    Normal (1)
    CL Item
    Proliferation of the bile ducts (bile ductular reaction) (2)
    CL Item
    Dilation, degeneration or disruption of portal bile ducts (3)
    CL Item
    Paucity of bile ducts (4)
    CL Item
    Periductal fibrosis (5)
    CL Item
    Other, specify (6)
    Other bile ducts
    Item
    If other bile ducts, specify.
    text
    C0005400 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Portal veins
    integer
    C0032718 (UMLS CUI [1])
    Portal veins
    Code List
    Portal veins
    CL Item
    Normal (1)
    CL Item
    Pyelophlebitis (2)
    CL Item
    Thrombosis, sclerosis or occlusion of portal vein (3)
    CL Item
    Neoplastic invasion of portal vein (4)
    CL Item
    Granulomatous compression of portal vein (5)
    CL Item
    6 Other, specify (6)
    Other portal vein structure
    Item
    If other portal vein structure, specify.
    text
    C0032718 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Liver infections
    integer
    C1112211 (UMLS CUI [1])
    Liver infections
    Code List
    Liver infections
    CL Item
    Normal (1)
    CL Item
    Leishmaniasis donovani (2)
    CL Item
    Plasmodium falciparum (3)
    CL Item
    Toxoplasmosis (4)
    CL Item
    Cryptococcus neoformans (5)
    CL Item
    Histoplasma capsulatum (6)
    CL Item
    Myobacterium tuberculosis (7)
    CL Item
    Other myobacterial species (8)
    CL Item
    Other, specify (9)
    Other liver infections
    Item
    If other liver infections, specify.
    text
    C1112211 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Parasites or Ova
    integer
    C0030498 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0555117 (UMLS CUI [1,3])
    Parasites or Ova
    Code List
    Parasites or Ova
    CL Item
    None (1)
    CL Item
    Schistosome and/ or ova (2)
    CL Item
    Ascaris and/ or ova (3)
    CL Item
    Toxocara and/ or ova (4)
    CL Item
    Echinococcus cysts (5)
    CL Item
    Hepatic capillariasis worms and/ or ova (6)
    CL Item
    Other, specify (7)
    Other parasites or ova
    Item
    If other parasites or ova, specify.
    text
    C0030498 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0555117 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    Item
    Histologic staining or additional studies obtained
    integer
    C0487602 (UMLS CUI [1,1])
    C0205462 (UMLS CUI [1,2])
    C2603343 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    Histologic staining or additional studies obtained
    Code List
    Histologic staining or additional studies obtained
    CL Item
    Haematoxylin and eosin (or H&E) (1)
    CL Item
    Masson (2)
    CL Item
    Toluidine blue or Giemsa (3)
    CL Item
    Prussian blue (4)
    CL Item
    Periodic Acidic Schiff (PAS), with or without diastase (5)
    CL Item
    Oil red O (6)
    CL Item
    Congo red (7)
    CL Item
    Hall's stain (8)
    CL Item
    Gridley's stain (9)
    CL Item
    Rhodanine (copper) (10)
    CL Item
    Rubeanic acid (copper) (11)
    CL Item
    Orcein, aldehyde fuchsin or Victoria blue (12)
    CL Item
    Electron microscopy (13)
    CL Item
    Hepatitis A immunostains positive (14)
    CL Item
    Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
    CL Item
    Hepatitis D immunostains (16)
    CL Item
    Other immunostains (17)
    CL Item
    Other, specify (18)
    Other histologic staining or additional studies
    Item
    If other histologic staining or additional studies obtained,l specify.
    text
    C0487602 (UMLS CUI [1,1])
    C0205462 (UMLS CUI [1,2])
    C2603343 (UMLS CUI [2,1])
    C1524062 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [3,1])
    C2348235 (UMLS CUI [3,2])
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