0 Ratings
ID

36383

Description

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Keywords

Versions (2)
  1. 5/6/19 5/6/19 -
  2. 5/8/19 5/8/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 8, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

    English

    Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

    1 forms  
    Date of Visit
    Description

    Date of Visit

    Alias
    UMLS CUI-1
    C1320303
    Date of Visit/ assessment
    Description

    Date of Visit/ assessment

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1320303
    UMLS CUI [1,2]
    C2985720
    Liver Event Assessment
    Description

    Liver Event Assessment

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    UMLS CUI-3
    C0220825
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Description

    If Yes, stop investigational product, complete date stopped on Investigational Product form, contact GSK within 24 hours of occurrence, complete Liver Events Form and obtain the following tests: * PK blood sample within 24 hours of last dose (or 3x the investigational product half life). * Hepatitis A: Hepatitis A IgM antibody. * Hepatitis B: Hepatitis B surface antigen and Hepatitis B Core Antibody (IgM). * Hepatitis C: Hepatitis C RNA. * Hepatitis E IgM antibody (if subject resides or has travelled in the past 3 months outside the USA or Canada). * Cytomegalovirus IgM antibody (CMV). * EBV (Epstein Barr viral capsid antigen IgM antibody) or if unavailable, obtain heterophile antibody or monospot testing.) * Bilirubin fractionation, if bilirubin >= 1.5xULN * CPK (serum creatine phosphokinase), * LDH (lactate dehydrogenase). The following are only needed when ALT >=3xULN and bilirubin >=1.5xULN (>35% direct) * Anti-nuclear antibody * Anti-smooth muscle antibody * Type 1 anti-liver kidney microsomal antibodies (if available) * Liver Imaging (ultrasound, magnetic resonance, or computerised tomography)

    Data type

    boolean

    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]
    C2746065
    UMLS CUI [2,3]
    C0243161
    Liver Events
    Description

    Liver Events

    Alias
    UMLS CUI-1
    C0023884
    UMLS CUI-2
    C0877248
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    Description

    Check all that apply

    Data type

    text

    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]
    C2746065
    UMLS CUI [2,3]
    C0243161
    Is the subject age 55 or older?
    Description

    Is the subject age 55 or older?

    Data type

    boolean

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

    If yes, ensure Pregnancy Notification Form has been completed.

    Data type

    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 resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    Description

    Were any diagnostic imaging tests of the liver or hepatobiliary system performed?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0011923
    UMLS CUI [1,2]
    C1711359
    UMLS CUI [2,1]
    C0011923
    UMLS CUI [2,2]
    C0023884
    UMLS CUI [3,1]
    C1456803
    UMLS CUI [3,2]
    C0023884
    UMLS CUI [4]
    C0040405
    UMLS CUI [5]
    C0436427
    UMLS CUI [6]
    C0024485
    UMLS CUI [7]
    C0008310
    If diagnostic imaging tests of liver or hepatobiliary system were performed, were the results normal?
    Description

    If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

    Data type

    boolean

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

    If yes, complete Liver Biopsy form.

    Data type

    boolean

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

    If yes, record on the appropriate Concomitant Medication form.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1360419
    UMLS CUI [2]
    C0002346
    UMLS CUI [3]
    C0242295
    UMLS CUI [4]
    C0042890
    UMLS CUI [5]
    C0086190
    Did the subject fast or undergo significant dietary change in the past week?
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3671772
    UMLS CUI [1,2]
    C2826293
    Investigational Product (Liver) - during treatment period
    Description

    Investigational Product (Liver) - during treatment period

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0023884
    UMLS CUI-3
    C0087111
    UMLS CUI-4
    C1948053
    UMLS CUI-5
    C0347984
    Start Date Investigational Product
    Description

    Start Date Investigational Product

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    Start Date Investigational Product
    Description

    Start Date Investigational Product

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    End Date Investigational Product
    Description

    End Date Investigational Product

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    End Date Investigational Product
    Description

    End Date Investigational Product

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    Investigational Product (Liver) - after treatment period
    Description

    Investigational Product (Liver) - after treatment period

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C0023884
    UMLS CUI-3
    C0087111
    UMLS CUI-4
    C1948053
    UMLS CUI-5
    C0347984
    UMLS CUI-6
    C0687676
    Start Date Investigational Product
    Description

    Start Date Investigational Product

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    Start Date Investigational Product
    Description

    Start Date Investigational Product

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    End Date Investigational Product
    Description

    End Date Investigational Product

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    End Date Investigational Product
    Description

    End Date Investigational Product

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    Pharmacokinetics (Liver PK)
    Description

    Pharmacokinetics (Liver PK)

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

    Was a pharmacokinetic blood sample obtained?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    If pharmacokinetic blood sample was obtained, enter date and time sample taken
    Description

    If pharmacokinetic blood sample was obtained, enter date and time sample taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [2,1]
    C0011008
    UMLS CUI [2,2]
    C0040223
    UMLS CUI [2,3]
    C0200345
    If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
    Description

    If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [2,1]
    C0304229
    UMLS CUI [2,2]
    C1762893
    UMLS CUI [3,1]
    C0304229
    UMLS CUI [3,2]
    C0946444
    Medical Conditions (Liver)
    Description

    Medical Conditions (Liver)

    Alias
    UMLS CUI-1
    C0012634
    UMLS CUI-2
    C0023884
    Acute Viral Hepatitis A
    Description

    Acute Viral Hepatitis A

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0276434
    Chronic Hepatitis B
    Description

    Chronic Hepatitis B

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0524909
    Chronic Hepatitis C
    Description

    Chronic Hepatitis C

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0524910
    Cytomegalovirus Hepatitis
    Description

    Cytomegalovirus Hepatitis

    Data type

    integer

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

    Epstein Barr Virus Infectious Mononucleosis

    Data type

    integer

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

    Herpes Simplex Hepatitis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1963747
    Alcoholic Liver Disease
    Description

    Alcoholic Liver Disease

    Data type

    integer

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

    Non-alcoholic Steatohepatitis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3241937
    Fatty Liver
    Description

    Fatty Liver

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0015695
    Hepatic Cirrhosis
    Description

    Hepatic Cirrhosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0023890
    Hemochromatosis
    Description

    Hemochromatosis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0018995
    Autoimmune Hepatitis
    Description

    Autoimmune Hepatitis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0241910
    Gallbladder disease or biliary disease
    Description

    Gallbladder disease or biliary disease

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0016977
    UMLS CUI [1,2]
    C3275124
    Drug related liver disease conditions
    Description

    Drug related liver disease conditions

    Alias
    UMLS CUI-1
    C0023895
    UMLS CUI-2
    C0277579
    Drug related liver disease
    Description

    Drug related liver disease

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0023895
    UMLS CUI [1,2]
    C0277579
    Other liver disease conditions
    Description

    Other liver disease conditions

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

    Sequence Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348184
    Specific Condition
    Description

    Specific Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Modified Term
    Description

    Modified Term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826302
    MedDRA Synonym
    Description

    MedDRA Synonym

    Data type

    text

    Alias
    UMLS CUI [1]
    C1140263
    MedDRA lower level term code
    Description

    MedDRA lower level term code

    Data type

    text

    Alias
    UMLS CUI [1]
    C3898442
    Failed coding
    Description

    Failed coding

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0805701
    UMLS CUI [1,2]
    C0231175
    Status
    Description

    Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C0449438
    Other medical conditions
    Description

    Other medical conditions

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

    Drug Allergies

    Data type

    integer

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

    Rheumatoid Arthritis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0003873
    Psoriasis
    Description

    Psoriasis

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0033860
    Thyroid Disease
    Description

    Thyroid Disease

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0040128
    Inflammatory Bowel Disease
    Description

    Inflammatory Bowel Disease

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0021390
    Lupus
    Description

    Lupus

    Data type

    integer

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

    Sjogren's Syndrome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1527336
    Vitiligo
    Description

    Vitiligo

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042900
    Alcohol intake
    Description

    Alcohol intake

    Alias
    UMLS CUI-1
    C0001948
    Does the subject consume alcohol?
    Description

    If yes, record the average number of units of alcohol consumed per week

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001948C0001948
    Average number of units of alcohol consumed per week
    Description

    Average number of units of alcohol consumed per week

    Data type

    float

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

    Liver imaging

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

    Date of hepatic or liver imaging test

    Data type

    date

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

    What method was used for this imaging test?

    Data type

    text

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

    If other method was used for this imaging test, specify

    Data type

    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?
    Description

    Are images technically adequate?

    Data type

    text

    Alias
    UMLS CUI [1]
    C0806487
    If other image quality, please specify
    Description

    If other image quality, please specify

    Data type

    text

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

    Indicate the liver size

    Data type

    text

    Alias
    UMLS CUI [1]
    C0426688
    If other liver size, please specify
    Description

    If other liver size, please specify

    Data type

    text

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

    Indicate the liver texture

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0679033
    UMLS CUI [1,2]
    C0023884
    If other liver texture, please specify
    Description

    If other liver texture, please specify

    Data type

    text

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

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

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015695
    UMLS CUI [1,2]
    C0205219
    UMLS CUI [2,1]
    C0015695
    UMLS CUI [2,2]
    C1517526
    If other diffuse and/or geographic fatty infiltrate of the liver, please specify
    Description

    If other diffuse and/or geographic fatty infiltrate of the liver, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015695
    UMLS CUI [1,2]
    C0205219
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0015695
    UMLS CUI [2,2]
    C1517526
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [2,4]
    C2348235
    Ascites present
    Description

    Ascites present

    Data type

    text

    Alias
    UMLS CUI [1]
    C0003962
    If other Ascites, please specify
    Description

    If other Ascites, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0003962
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Are Focal Hepatic Lesions characterisable?
    Description

    Are Focal Hepatic Lesions characterisable?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    If Focal Hepatic Lesions are characterisable, check all that apply
    Description

    If Focal Hepatic Lesions are characterisable, check all that apply

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    If other Focal Hepatic Lesions, please specify
    Description

    If other Focal Hepatic Lesions, please specify

    Data type

    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?
    Description

    Gallstones or gallbladder lesions?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3842395
    UMLS CUI [1,2]
    C0221198
    If gallstones or gallbladder lesions are present, check all that apply
    Description

    If gallstones or gallbladder lesions are present, check all that apply

    Data type

    text

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

    If other gallstones or gallbladder lesions, please specify

    Data type

    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?
    Description

    Biliary ductal lesions?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    If biliary ductal lesions are present, check all that apply
    Description

    If biliary ductal lesions are present, check all that apply

    Data type

    text

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

    If other biliary ductal lesions, please specify

    Data type

    text

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

    Portal/Hepatic vein abnormalities?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0032718
    If portal/ hepatic vein abnormalities are present, check all that apply
    Description

    If portal/ hepatic vein abnormalities are present, check all that apply

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0032718
    If other portal/ hepatic vein abnormalities, please specify
    Description

    If other portal/ hepatic vein abnormalities, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0032718
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
    Liver Biopsy
    Description

    Liver Biopsy

    Alias
    UMLS CUI-1
    C0193388
    Date of liver biopsy
    Description

    Date of liver biopsy

    Data type

    date

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

    Approximate size of liver biopsy

    Data type

    integer

    Measurement units
    • mm
    Alias
    UMLS CUI [1,1]
    C1299482
    UMLS CUI [1,2]
    C0193388
    mm
    Biopsy size unit
    Description

    Biopsy size unit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1299482
    UMLS CUI [1,2]
    C1519795
    UMLS CUI [1,3]
    C0193388
    Final Diagnosis
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C1546485
    If other final diagnosis, please specify
    Description

    If other final diagnosis, please specify

    Data type

    text

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

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0023884
    UMLS CUI [1,2]
    C0935919
    If other liver architecture, please specify
    Description

    If other liver architecture, please specify

    Data type

    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
    Description

    Check all that apply

    Data type

    text

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

    If other description of liver cells or hepatocytes

    Data type

    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
    Description

    Check all that apply

    Data type

    text

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

    If other liver cell or hepatocyte inclusions or vacuoles, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0227525
    UMLS CUI [1,2]
    C1512693
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0042219
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Hepatocyte or Liver Cell Nuclear Abnormalities
    Description

    Check all that apply

    Data type

    text

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

    If other hepatocyte or liver cell nuclear abnormalities

    Data type

    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
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C1400896
    If other liver or lobular infiltrates, please specify
    Description

    If other liver or lobular infiltrates, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1400896
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Portal Tract Inflammation
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C3854488
    If other portal tract inflammation, please specify
    Description

    If other portal tract inflammation, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3854488
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Bile Ducts
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C0005400
    If other bile ducts, please specify
    Description

    If other bile ducts, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0005400
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Portal Veins
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032718
    If other portal veins, please specify
    Description

    If other portal veins, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0032718
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Liver Infections
    Description

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1]
    C1112211
    If other liver infections, please specify
    Description

    If other liver infections, please specify

    Data type

    text

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

    Check all that apply

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030498
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [2]
    C0555117
    If other parasites or ova, please specify
    Description

    If other parasites or ova, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0030498
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0555117
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C2348235
    Histologic Staining or Additional Studies Obtained
    Description

    Histologic Staining or Additional Studies Obtained

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0487602
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C1524062
    If other histologic staining or additional studies obtained, please specify
    Description

    If other histologic staining or additional studies obtained, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0487602
    UMLS CUI [1,2]
    C0023884
    UMLS CUI [1,3]
    C1524062
    UMLS CUI [1,4]
    C0205394
    UMLS CUI [1,5]
    C2348235
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    Similar models

    Liver Event - Liver Events; Investigational Product; Pharmacokinetics; Medical Conditions; Alcohol Intake; Liver Imaging; Liver Biopsy

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit
    C1320303 (UMLS CUI-1)
    Date of Visit/ assessment
    Item
    Date of Visit/ assessment
    date
    C1320303 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    Item Group
    Liver Event Assessment
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    C0220825 (UMLS CUI-3)
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    Item
    Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
    boolean
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C2746065 (UMLS CUI [2,2])
    C0243161 (UMLS CUI [2,3])
    Item Group
    Liver Events
    C0023884 (UMLS CUI-1)
    C0877248 (UMLS CUI-2)
    Item
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    text
    C0232741 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [1,3])
    C0304229 (UMLS CUI [2,1])
    C2746065 (UMLS CUI [2,2])
    C0243161 (UMLS CUI [2,3])
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    Code List
    Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
    CL Item
    ALT (alanine aminotransferase) (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 (OT)
    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)
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed?
    Item
    Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
    boolean
    C0011923 (UMLS CUI [1,1])
    C1711359 (UMLS CUI [1,2])
    C0011923 (UMLS CUI [2,1])
    C0023884 (UMLS CUI [2,2])
    C1456803 (UMLS CUI [3,1])
    C0023884 (UMLS CUI [3,2])
    C0040405 (UMLS CUI [4])
    C0436427 (UMLS CUI [5])
    C0024485 (UMLS CUI [6])
    C0008310 (UMLS CUI [7])
    If diagnostic imaging tests of liver were performed, were the results normal?
    Item
    If diagnostic imaging tests of liver or hepatobiliary system were performed, were the results normal?
    boolean
    C0011923 (UMLS CUI [1,1])
    C1711359 (UMLS CUI [1,2])
    C1274040 (UMLS CUI [1,3])
    C0011923 (UMLS CUI [2,1])
    C0023884 (UMLS CUI [2,2])
    C1274040 (UMLS CUI [2,3])
    Were any liver biopsies performed?
    Item
    Were any liver biopsies performed?
    boolean
    C0193388 (UMLS CUI [1])
    Does the subject use 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
    C1360419 (UMLS CUI [1])
    C0002346 (UMLS CUI [2])
    C0242295 (UMLS CUI [3])
    C0042890 (UMLS CUI [4])
    C0086190 (UMLS CUI [5])
    Did the subject fast or undergo significant dietary change in the past week?
    Item
    Did the subject fast or undergo significant dietary change in the past week?
    boolean
    C3671772 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Item Group
    Investigational Product (Liver) - during treatment period
    C0304229 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    C0087111 (UMLS CUI-3)
    C1948053 (UMLS CUI-4)
    C0347984 (UMLS CUI-5)
    Start Date Investigational Product
    Item
    Start Date Investigational Product
    date
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Start Date Investigational Product
    integer
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Date Investigational Product
    Code List
    Start Date Investigational Product
    CL Item
    Not applicable (1)
    End Date Investigational Product
    Item
    End Date Investigational Product
    date
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    End Date Investigational Product
    integer
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    End Date Investigational Product
    Code List
    End Date Investigational Product
    CL Item
    Not applicable (1)
    Item Group
    Investigational Product (Liver) - after treatment period
    C0304229 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    C0087111 (UMLS CUI-3)
    C1948053 (UMLS CUI-4)
    C0347984 (UMLS CUI-5)
    C0687676 (UMLS CUI-6)
    Start Date Investigational Product
    Item
    Start Date Investigational Product
    date
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Item
    Start Date Investigational Product
    integer
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Date Investigational Product
    Code List
    Start Date Investigational Product
    CL Item
    Not applicable (1)
    End Date Investigational Product
    Item
    End Date Investigational Product
    datetime
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    End Date Investigational Product
    integer
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    End Date Investigational Product
    Code List
    End Date Investigational Product
    CL Item
    Not applicable (1)
    Item Group
    Pharmacokinetics (Liver PK)
    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])
    If pharmacokinetic blood sample was obtained, enter date and time sample taken
    Item
    If pharmacokinetic blood sample was obtained, enter date and time sample taken
    datetime
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [2,1])
    C0040223 (UMLS CUI [2,2])
    C0200345 (UMLS CUI [2,3])
    If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
    Item
    If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
    datetime
    C0005834 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [2,1])
    C1762893 (UMLS CUI [2,2])
    C0304229 (UMLS CUI [3,1])
    C0946444 (UMLS CUI [3,2])
    Item Group
    Medical Conditions (Liver)
    C0012634 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    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 (5)
    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 (5)
    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 (5)
    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 (5)
    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 (5)
    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 (5)
    Item
    Alcoholic Liver Disease
    integer
    C0023896 (UMLS CUI [1])
    undefined item
    Code List
    Alcoholic Liver Disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    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 (5)
    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 (5)
    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 (5)
    Item
    Hemochromatosis
    integer
    C0018995 (UMLS CUI [1])
    Hemochromatosis
    Code List
    Hemochromatosis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    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 (5)
    Item
    Gallbladder disease or biliary disease
    integer
    C0016977 (UMLS CUI [1,1])
    C3275124 (UMLS CUI [1,2])
    Gallbladder disease or biliary disease
    Code List
    Gallbladder disease or biliary disease
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    Item Group
    Drug related liver disease conditions
    C0023895 (UMLS CUI-1)
    C0277579 (UMLS CUI-2)
    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 (5)
    Item Group
    Other liver disease conditions
    C0023895 (UMLS CUI-1)
    C0205394 (UMLS CUI-2)
    Sequence Number
    Item
    Sequence Number
    integer
    C2348184 (UMLS CUI [1])
    Specific Condition
    Item
    Specific Condition
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Modified Term
    Item
    Modified Term
    text
    C2826302 (UMLS CUI [1])
    MedDRA Synonym
    Item
    MedDRA Synonym
    text
    C1140263 (UMLS CUI [1])
    MedDRA lower level term code
    Item
    MedDRA lower level term code
    text
    C3898442 (UMLS CUI [1])
    Failed coding
    Item
    Failed coding
    text
    C0805701 (UMLS CUI [1,1])
    C0231175 (UMLS CUI [1,2])
    Item
    Status
    text
    C0449438 (UMLS CUI [1])
    Status
    Code List
    Status
    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 (5)
    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 (5)
    Item
    Psoriasis
    integer
    C0033860 (UMLS CUI [1])
    Psoriasis
    Code List
    Psoriasis
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    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 (5)
    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 (5)
    Item
    Lupus
    integer
    C0409974 (UMLS CUI [1])
    Lupus
    Code List
    Lupus
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    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 (5)
    Item
    Vitiligo
    integer
    C0042900 (UMLS CUI [1])
    Vitiligo
    Code List
    Vitiligo
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No Medical Condition (5)
    Item Group
    Alcohol intake
    C0001948 (UMLS CUI-1)
    Does the subject consume alcohol?
    Item
    Does the subject consume alcohol?
    boolean
    C0001948C0001948 (UMLS CUI [1])
    Average number of units of alcohol consumed per week
    Item
    Average number of units of alcohol consumed per week
    float
    C0001948 (UMLS CUI [1,1])
    C0560579 (UMLS CUI [1,2])
    Item Group
    Liver imaging
    C2711860 (UMLS CUI-1)
    Date of hepatic or liver imaging test
    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?
    text
    C2711860 (UMLS CUI [1,1])
    C1275506 (UMLS CUI [1,2])
    What method was 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: A200 (OT)
    If other method was used for this imaging test, specify
    Item
    If other method was used for this 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?
    text
    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: (OT)
    If other image quality, please specify
    Item
    If other image quality, please specify
    text
    C0806487 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Indicate the liver size
    text
    C0426688 (UMLS CUI [1])
    Indicate the liver size
    Code List
    Indicate the liver size
    CL Item
    Normal size (A1)
    CL Item
    Hypertrophy (or enlarged) (A2)
    CL Item
    Atrophy (or smaller than normal) (A3)
    CL Item
    Segmental hypertrophy (A4)
    CL Item
    Other, specify: (A99)
    If other liver size, please specify
    Item
    If other liver size, please specify
    text
    C0426688 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Indicate the liver texture
    text
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    Indicate the liver texture
    Code List
    Indicate the liver texture
    CL Item
    Normal (B1)
    CL Item
    Heterogenous (B2)
    CL Item
    Suggestive of fibrosis (B3)
    CL Item
    Nodular or suggestive of cirrhosis (B4)
    CL Item
    Other, specify (B99)
    If other liver texture, please specify
    Item
    If other liver texture, please specify
    text
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Item
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    text
    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 (C1)
    CL Item
    Mild (<=25%) (C2)
    CL Item
    Moderate (>25% to <75%) (C3)
    CL Item
    Severe (>=75%) (C4)
    CL Item
    Other, specify (C99)
    If other diffuse and/or geographic fatty infiltrate of the liver, please specify
    Item
    If other diffuse and/or geographic fatty infiltrate of the liver, please specify
    text
    C0015695 (UMLS CUI [1,1])
    C0205219 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0015695 (UMLS CUI [2,1])
    C1517526 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C2348235 (UMLS CUI [2,4])
    Item
    Ascites present
    text
    C0003962 (UMLS CUI [1])
    Ascites present
    Code List
    Ascites present
    CL Item
    None present (D1)
    CL Item
    Yes - small amount (D2)
    CL Item
    Yes - moderate or severe amount (D3)
    CL Item
    Other, specify (D99)
    If other Ascites, please specify
    Item
    If other Ascites, please specify
    text
    C0003962 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Are Focal Hepatic Lesions characterisable?
    Item
    Are Focal Hepatic Lesions characterisable?
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    Item
    If Focal Hepatic Lesions are characterisable, check all that apply
    text
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    If Focal Hepatic Lesions are characterisable, check all that apply
    Code List
    If Focal Hepatic Lesions are characterisable, check all that apply
    CL Item
    Solid (E1)
    CL Item
    Cystic (E2)
    CL Item
    Hemangioma (E3)
    CL Item
    Focal Nodular Hyperplasia (E4)
    CL Item
    Other, specify (E99)
    If other Focal Hepatic Lesions, please specify
    Item
    If other Focal Hepatic Lesions, please specify
    text
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Gallstones or gallbladder lesions?
    Item
    Gallstones or gallbladder lesions?
    boolean
    C3842395 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    If gallstones or gallbladder lesions are present, check all that apply
    text
    C3842395 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    If gallstones or gallbladder lesions are present, check all that apply
    Code List
    If gallstones or gallbladder lesions are present, check all that apply
    CL Item
    Gallstones (F1)
    CL Item
    Gallbladder polyp(s) (F2)
    CL Item
    Sludge (F3)
    CL Item
    Gallbladder wall thickening/oedema (F4)
    CL Item
    Gallbladder wall gas (F5)
    CL Item
    Cholecystitis (F6)
    CL Item
    Gallbladder wall calcification (F7)
    CL Item
    Gallbladder mass (F8)
    CL Item
    Other, specify (F99)
    If other gallstones or gallbladder lesions, please specify
    Item
    If other gallstones or gallbladder lesions, please specify
    text
    C3842395 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Biliary ductal lesions?
    Item
    Biliary ductal lesions?
    boolean
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Item
    If biliary ductal lesions are present, check all that apply
    text
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    If biliary ductal lesions are present, check all that apply
    Code List
    If biliary ductal lesions are present, check all that apply
    CL Item
    Intrahepatic ductal dilation (focal involving the right hepatic lobe) (G1)
    CL Item
    Intrahepatic ductal dilation (focal involving the left hepatic lobe) (G2)
    CL Item
    Intrahepatic ductal dilation (focal involving both right and left hepatic lobes) (G3)
    CL Item
    Extrahepatic ductal dilation (G4)
    CL Item
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (G5)
    CL Item
    Acute Cholangitis (G6)
    CL Item
    Primary sclerosing cholangitis (G7)
    CL Item
    Choledocholithiasis (gallstone in duct) (G8)
    CL Item
    Ductal filling defect(s), other than gallstone (G9)
    CL Item
    Ductal wall thickening or oedema (G10)
    CL Item
    Choledochal cyst (G11)
    CL Item
    Ductal mass (G12)
    CL Item
    Extrinsic mass compressing bile duct(s) (G13)
    CL Item
    Other, specify (G99)
    If other biliary ductal lesions, please specify
    Item
    If other biliary ductal lesions, please specify
    text
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Portal/Hepatic vein abnormalities?
    Item
    Portal/Hepatic vein abnormalities?
    boolean
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [1,3])
    Item
    If portal/ hepatic vein abnormalities are present, check all that apply
    text
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [1,3])
    If portal/ hepatic vein abnormalities are present, check all that apply
    Code List
    If portal/ hepatic vein abnormalities are present, check all that apply
    CL Item
    Portal vein enlargement (H1)
    CL Item
    Hepatic vein enlargement (H2)
    CL Item
    Nonocclusive portal vein thrombosis (H3)
    CL Item
    Occlusive portal vein thrombosis - bland (H4)
    CL Item
    Hepatic vein thrombosis - bland (H5)
    CL Item
    Occlusive portal vein thrombosis - malignant (H6)
    CL Item
    Hepatic vein thrombosis - malignant (H7)
    CL Item
    Involvement of the main portal vein (H8)
    CL Item
    Involvement of the right portal vein (H9)
    CL Item
    Involvement of the left portal vein (H10)
    CL Item
    Budd-Chiari syndrome (H11)
    CL Item
    Other, specify (H99)
    If other portal/ hepatic vein abnormalities, please specify
    Item
    If other portal/ hepatic vein abnormalities, please specify
    text
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
    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
    integer
    C1299482 (UMLS CUI [1,1])
    C0193388 (UMLS CUI [1,2])
    Biopsy size unit
    Item
    Biopsy size unit
    text
    C1299482 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    C0193388 (UMLS CUI [1,3])
    Item
    Final Diagnosis
    text
    C1546485 (UMLS CUI [1])
    Final Diagnosis
    Code List
    Final Diagnosis
    CL Item
    Normal (A0)
    CL Item
    Acute hepatitis (A1)
    CL Item
    Chronic hepatitis (A2)
    CL Item
    Cholestatic hepatitis (A3)
    CL Item
    Drug-induced cholestasis (A4)
    CL Item
    Acute viral hepatitis (A5)
    CL Item
    Chronic viral hepatitis (A6)
    CL Item
    Drug-induced hepatitis (A7)
    CL Item
    Autoimmune hepatitis (A8)
    CL Item
    Bridging necrosis (A9)
    CL Item
    Submassive hepatic necrosis (A10)
    CL Item
    Massive hepatic necrosis (A11)
    CL Item
    Steatosis - microvesicular (A12)
    CL Item
    Steatosis - macrovesicular (A13)
    CL Item
    Steatosis - mixed (A14)
    CL Item
    Non-alcoholic steatohepatitis (A15)
    CL Item
    Alcoholic hepatitis (A16)
    CL Item
    Hepatic granulomas (A17)
    CL Item
    Sarcoidosis (A18)
    CL Item
    Fibrosis (A19)
    CL Item
    Cirrhosis (A20)
    CL Item
    Primary biliary cirrhosis (A21)
    CL Item
    Primary sclerosing cholangitis (A22)
    CL Item
    Autoimmune overlap syndrome (A23)
    CL Item
    Hemochromatosis (A24)
    CL Item
    Alpha-1-antitrypsin deficiency (A25)
    CL Item
    Wilson's disease (A26)
    CL Item
    Veno-occlusive disease (A27)
    CL Item
    Budd-Chiari syndrome (A28)
    CL Item
    Neoplasia (A29)
    CL Item
    Other, specify (A99)
    If other final diagnosis, please specify
    Item
    If other final diagnosis, please specify
    text
    C1546485 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Liver Architecture
    text
    C0023884 (UMLS CUI [1,1])
    C0935919 (UMLS CUI [1,2])
    Liver Architecture
    Code List
    Liver Architecture
    CL Item
    Normal (B1)
    CL Item
    Bridging fibrosis (B2)
    CL Item
    Diffuse fibrosis (B3)
    CL Item
    Nodular regenerative hyperplasia (B4)
    CL Item
    Congenital hepatic fibrosis (B5)
    CL Item
    Cirrhosis (B6)
    CL Item
    Centrilobular congestion (B7)
    CL Item
    Endophlebitis (B8)
    CL Item
    Veno-occlusive disease (B9)
    CL Item
    Canalicular cholestasis (B10)
    CL Item
    Apoptosis (B11)
    CL Item
    Focal (or spotty or mild) hepatocellular necrosis (B12)
    CL Item
    Interface hepatitis (periportal hepatitis or piecemeal necrosis) (B13)
    CL Item
    Ischaemic necrosis (B14)
    CL Item
    Centrolobular (Zone 3) necrosis (B15)
    CL Item
    Focal coagulative necrosis (B16)
    CL Item
    Centrolobular (Zone 3) coagulative necrosis (B17)
    CL Item
    Bridging hepatocellular necrosis (B18)
    CL Item
    Massive or panlobular hepatocellular necrosis (B19)
    CL Item
    Dysplasia (B20)
    CL Item
    Neoplasia (B21)
    CL Item
    Other, specify (B99)
    If other liver architecture, please specify
    Item
    If other liver architecture, please 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
    text
    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 (C0)
    CL Item
    Ballooning (C1)
    CL Item
    Acidophilic (C2)
    CL Item
    Pseudoxanthomatous (C3)
    CL Item
    Multinucleated giant hepatocytes (C4)
    CL Item
    Other, specify (C99)
    If other description of liver cells or hepatocytes
    Item
    If other description of liver cells or hepatocytes
    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
    text
    C0227525 (UMLS CUI [1,1])
    C1512693 (UMLS CUI [1,2])
    C0042219 (UMLS CUI [2])
    Liver Cell or Hepatocyte Inclusions or Vacuoles
    Code List
    Liver Cell or Hepatocyte Inclusions or Vacuoles
    CL Item
    No inclusions (D0)
    CL Item
    Macrovesicular steatosis (D1)
    CL Item
    Microvesicular steatosis (D2)
    CL Item
    Bile accumulation (D3)
    CL Item
    Diastase-resistant, PAS-positive cytoplasmic inclusions (D4)
    CL Item
    Alpha-1-antitrypsin inclusions (D5)
    CL Item
    Megamitochondria (D6)
    CL Item
    Mallory bodies (D7)
    CL Item
    "Ground Glass" inclusions (D8)
    CL Item
    Lipofuscin pigment (D9)
    CL Item
    Hemosiderin granules (D10)
    CL Item
    Orcein-positive cytoplasmin granules (D11)
    CL Item
    Protoporphyrin crystals (birefringent under polarised light) (D12)
    CL Item
    Uroporphyrin crystals (red fluorescence under ultraviolet light) (D13)
    CL Item
    Other, specify (D99)
    If other liver cell or hepatocyte inclusions or vacuoles, please specify
    Item
    If other liver cell or hepatocyte inclusions or vacuoles, please specify
    text
    C0227525 (UMLS CUI [1,1])
    C1512693 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0042219 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Hepatocyte or Liver Cell Nuclear Abnormalities
    text
    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 (E0)
    CL Item
    Hepatocellular mitosis (E1)
    CL Item
    Binucleated or multinucleated hepatocytes (E2)
    CL Item
    CMV inclusion bodies (E3)
    CL Item
    HSV inclusions (E4)
    CL Item
    Varicella inclusions (E5)
    CL Item
    Other, specify (E99)
    If other hepatocyte or liver cell nuclear abnormalities
    Item
    If other hepatocyte or liver cell nuclear abnormalities
    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
    text
    C1400896 (UMLS CUI [1])
    Liver or Lobular Infiltrates
    Code List
    Liver or Lobular Infiltrates
    CL Item
    None (F0)
    CL Item
    Eosinophils (F1)
    CL Item
    Lymphocytes (F2)
    CL Item
    Plasma cells (F3)
    CL Item
    Neutrophils (F4)
    CL Item
    Macrophages and proliferating Kupffer cells (F5)
    CL Item
    Granulomas (F6)
    CL Item
    Other, specify (F99)
    If other liver or lobular infiltrates, please specify
    Item
    If other liver or lobular infiltrates, please specify
    text
    C1400896 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Portal Tract Inflammation
    text
    C3854488 (UMLS CUI [1])
    Portal Tract Inflammation
    Code List
    Portal Tract Inflammation
    CL Item
    None (G0)
    CL Item
    Eosinophils (G1)
    CL Item
    Lymphoid aggregates and/or follicles (G2)
    CL Item
    Plasma cells (G3)
    CL Item
    Neutrophils (G4)
    CL Item
    Histocytes and macrophages (G5)
    CL Item
    Other, specify (G99)
    If other portal tract inflammation, please specify
    Item
    If other portal tract inflammation, please specify
    text
    C3854488 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Bile Ducts
    text
    C0005400 (UMLS CUI [1])
    Bile Ducts
    Code List
    Bile Ducts
    CL Item
    Normal (H0)
    CL Item
    Proliferation of bile ducts (bile ductular reaction) (H1)
    CL Item
    Dilation, degeneration or disruption of portal bile ducts (H2)
    CL Item
    Paucity of bile ducts (H3)
    CL Item
    Periductal fibrosis (H4)
    CL Item
    Other, specify (H99)
    If other bile ducts, please specify
    Item
    If other bile ducts, please specify
    text
    C0005400 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Portal Veins
    text
    C0032718 (UMLS CUI [1])
    Portal Veins
    Code List
    Portal Veins
    CL Item
    Normal (I0)
    CL Item
    Pyelophlebitis (I1)
    CL Item
    Thrombosis, sclerosis or occlusion of portal vein (I2)
    CL Item
    Neoplastic invasion of portal vein (I3)
    CL Item
    Granulomatous compression of portal vein (I4)
    CL Item
    Other, specify (I99)
    If other portal veins, please specify
    Item
    If other portal veins, please specify
    text
    C0032718 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Liver Infections
    text
    C1112211 (UMLS CUI [1])
    Liver Infections
    Code List
    Liver Infections
    CL Item
    Normal (J0)
    CL Item
    Leishmaniasis donovani (J1)
    CL Item
    Plasmodium falciparum (J2)
    CL Item
    Toxoplasmosis (J3)
    CL Item
    Cryptococcus neoformans (J4)
    CL Item
    Histoplasma capsulatum (J5)
    CL Item
    Mycobacterium tuberculois (J6)
    CL Item
    Other mycobacterial species (J7)
    CL Item
    Other, specify (J99)
    If other liver infections, please specify
    Item
    If other liver infections, please specify
    text
    C1112211 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item
    Parasites or Ova
    text
    C0030498 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0555117 (UMLS CUI [2])
    Parasites or Ova
    Code List
    Parasites or Ova
    CL Item
    None (K0)
    CL Item
    Schistosome and/or ova (K1)
    CL Item
    Ascaris and/or ova (K2)
    CL Item
    Toxocara and/or ova (K3)
    CL Item
    Echinococcus cysts (K4)
    CL Item
    Hepatic capillariasis worms and/or ova (K5)
    CL Item
    Other, specify (K99)
    If other parasites or ova, please specify
    Item
    If other parasites or ova, please specify
    text
    C0030498 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0555117 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C2348235 (UMLS CUI [2,3])
    Item
    Histologic Staining or Additional Studies Obtained
    text
    C0487602 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    Histologic Staining or Additional Studies Obtained
    Code List
    Histologic Staining or Additional Studies Obtained
    CL Item
    Haematoxylin and eosin (or H & E) (L1)
    CL Item
    Masson (L2)
    CL Item
    Toluidine blue or Giemsa (L3)
    CL Item
    Prussian blue (L4)
    CL Item
    Periodic Acidic Schiff (PAS), with or without diastase (L5)
    CL Item
    Oil red O (L6)
    CL Item
    Congo red (L7)
    CL Item
    Hall's stain (L8)
    CL Item
    Gridley's stain (L9)
    CL Item
    Rhodanine (copper) (L10)
    CL Item
    Rubeanic acid (copper)  (L11)
    CL Item
    Orcein, aldehyde fuchsin or Victoria blue (L12)
    CL Item
    Electron microscopy (L13)
    CL Item
    Hepatitis A immunostains positive (L14)
    CL Item
    Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (L15)
    CL Item
    Hepatitis D immunostains (L16)
    CL Item
    Other immunostains (L17)
    CL Item
    Other, specify (L99)
    If other histologic staining or additional studies obtained, please specify
    Item
    If other histologic staining or additional studies obtained, please specify
    text
    C0487602 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C1524062 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    C2348235 (UMLS CUI [1,5])
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