ID

38578

Beschreibung

Study ID: 108062 Clinical Study ID: 108062 Study Title: A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00908037 https://clinicaltrials.gov/ct2/show/NCT00908037 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: eltrombopag, Placebo Trade Name: N/A Study Indication: Purpura, Thrombocytopaenic, Idiopathic The study consists of a screening, Day 1 and three parts. All subjects were supposed to receive 24 weeks (6 months) of eltrombopag treatment during Part 2/3. Screening period: Up to 28 days prior to Day 1 of treatment. Day 1 Part 1 (Dose Finding Phase): A 24-week (6 months) open label treatment period for 5 subjects in each age cohort. (short: P1W1-P1W7, P1W8-23, P1W24/EW). A safety, PK and platelet count review took place after 12 weeks (3 months) of treatment. Subjects in the Dose Finding Phase did not participate in the Randomized Period. Part 2 (Randomized Period): A 7-week randomized, double-blind, placebo-controlled period involving 18 subjects per cohort (short: P2W1-P2W7). Part 3: An open-label treatment period where subjects randomized to eltrombopag in Part 2 received an additional 17 weeks of eltrombopag in Part 3 and subjects randomized to placebo in Part 2 received 24 weeks of eltrombopag in Part 3 (short: P3W8-P3W23, P3W24/EW, P3W8-30, P3W31/EW). Follow-up: 4 weeks following the last dose of eltrombopag (short: FUW1- FUW4). Additional ocular examinations were performed at 12 and 24 weeks (3 and 6 months) after the last dose of eltrombopag (short: FUM3, FUM6). The subjects were enrolled in 3 cohorts: Cohort 1: Subjects between 12 and 17 years old (<18 years of age at Day 1). Cohort 2: Subjects between 6 and 11 years old (<12 years of age at Day 1). Cohort 3: Subjects between 1 and 5 years old (<6 years of age at Day 1). The enrollment was started with the oldest cohort (Cohort 1). The younger cohorts were not enrolled until safety, PK and platelet counts had been reviewed in the older cohort(s). This document contains the liver imaging form. It has to be filled in if a liver imaging was taken during study.

Link

https://clinicaltrials.gov/ct2/show/NCT00908037

Stichworte

Versionen (1)
  1. 24.10.19 24.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

24. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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    Effects of eltrombopag in children with chronic idiopathic thrombocytopenic purpura, NCT00908037

    Englisch

    Liver Imaging

    1 Formulare  
    1. StudyEvent: ODM
      1. Liver Imaging
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschreibung

    Subject number

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Liver imaging
    Beschreibung

    Liver imaging

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

    day month year

    Datentyp

    date

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

    What method was used for this imaging test?

    Alias
    UMLS CUI-1
    C2711860
    UMLS CUI-2
    C0871511
    Method
    Beschreibung

    Method

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0871511
    If other method, please specify
    Beschreibung

    Other method

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0871511
    UMLS CUI [1,2]
    C0205394
    Are images technically adequate?
    Beschreibung

    Are images technically adequate?

    Alias
    UMLS CUI-1
    C0806487
    Image quality
    Beschreibung

    Image quality

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0806487
    If Other quality appearance, please specify
    Beschreibung

    Other quality appearance

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0806487
    UMLS CUI [1,2]
    C0205394
    Indicate the liver size
    Beschreibung

    Indicate the liver size

    Alias
    UMLS CUI-1
    C0426688
    Liver size
    Beschreibung

    Liver size

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0426688
    If Other liver size, please specify
    Beschreibung

    Other liver size

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0426688
    UMLS CUI [1,2]
    C0205394
    Indicate the liver texture
    Beschreibung

    Indicate the liver texture

    Alias
    UMLS CUI-1
    C0679033
    UMLS CUI-2
    C0023884
    Liver texture
    Beschreibung

    Liver texture

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0679033
    UMLS CUI [1,2]
    C0023884
    If Other liver texture, please specify
    Beschreibung

    Other liver texture

    Datentyp

    text

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

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

    Alias
    UMLS CUI-1
    C0015695
    UMLS CUI-2
    C0205219
    UMLS CUI-3
    C0015695
    UMLS CUI-4
    C1517526
    Diffuse and/or geographic fatty infiltrate of liver
    Beschreibung

    Diffuse and/or geographic fatty infiltrate of liver

    Datentyp

    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 liver, please specify
    Beschreibung

    Other diffuse and/or geographic fatty infiltrate of liver

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0015695
    UMLS CUI [1,3]
    C0205219
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C0015695
    UMLS CUI [2,3]
    C1517526
    Ascites present
    Beschreibung

    Ascites present

    Alias
    UMLS CUI-1
    C0003962
    Ascites status
    Beschreibung

    Ascites status

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0003962
    UMLS CUI [1,2]
    C0449438
    If Other ascites status, please specify
    Beschreibung

    Other ascites status

    Datentyp

    text

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

    Are Focal Hepatic Lesions characterisable?

    Alias
    UMLS CUI-1
    C0577053
    UMLS CUI-2
    C0205234
    Focal hepatic lesions: Not applicable - no hepatic lesions
    Beschreibung

    Focal hepatic lesions: Not applicable - no hepatic lesions

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1272460
    UMLS CUI [2,1]
    C0577053
    UMLS CUI [2,2]
    C0205234
    UMLS CUI [2,3]
    C1298908
    Focal hepatic lesions: Solid
    Beschreibung

    Focal hepatic lesions: Solid

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205208
    Focal hepatic lesions: Cystic
    Beschreibung

    Focal hepatic lesions: Cystic

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205207
    Focal hepatic lesions: Hemangioma
    Beschreibung

    Focal hepatic lesions: Hemangioma

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0018916
    Focal hepatic lesions: Focal Nodular Hyperplasia
    Beschreibung

    Focal hepatic lesions: Focal Nodular Hyperplasia

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0020510
    Focal hepatic lesions: Other
    Beschreibung

    Focal hepatic lesions: Other

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205394
    If other Focal hepatic lesions, please specify
    Beschreibung

    Focal hepatic lesions: Other, specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205394
    Gallstones or gallbladder lesions
    Beschreibung

    Gallstones or gallbladder lesions

    Alias
    UMLS CUI-1
    C3842395
    UMLS CUI-2
    C0221198
    No Gallstones or gallbladder lesions
    Beschreibung

    No Gallstones or gallbladder lesions

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1298908
    UMLS CUI [1,2]
    C3842395
    UMLS CUI [2,1]
    C1298908
    UMLS CUI [2,2]
    C0221198
    Gallstones
    Beschreibung

    Gallstones

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0008350
    Gallbladder polyp(s)
    Beschreibung

    Gallbladder polyps

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0262493
    Sludge
    Beschreibung

    Sludge

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0860209
    Gallbladder wall thickening/oedema
    Beschreibung

    Gallbladder wall thickening/oedema

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0744257
    UMLS CUI [2,1]
    C0734014
    UMLS CUI [2,2]
    C0013604
    Gallbladder wall gas
    Beschreibung

    Gallbladder wall gas

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2246573
    UMLS CUI [1,2]
    C0016976
    Cholecystitis
    Beschreibung

    Cholecystitis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0008325
    Gallbladder wall calcification
    Beschreibung

    Gallbladder wall calcification

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0016976
    UMLS CUI [1,2]
    C1533591
    Gallbladder mass
    Beschreibung

    Gallbladder mass

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0016976
    UMLS CUI [1,2]
    C0577559
    Other gallbladder lesions
    Beschreibung

    Other gallbladder lesions

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0156213
    If Other gallbladder lesions, please specify
    Beschreibung

    Other gallbladder lesions specification

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0156213
    Biliary ductal lesions
    Beschreibung

    Biliary ductal lesions

    Alias
    UMLS CUI-1
    C0005423
    UMLS CUI-2
    C0221198
    UMLS CUI-3
    C2711860
    No Biliary ductal lesions
    Beschreibung

    No Biliary ductal lesions

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C2711860
    UMLS CUI [1,4]
    C1298908
    Intrahepatic ductal dilation (focal involving the right hepatic lobe)
    Beschreibung

    Intrahepatic ductal dilation, right lobe

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0545796
    UMLS CUI [1,2]
    C0012359
    UMLS CUI [1,3]
    C0227481
    UMLS CUI [1,4]
    C2711860
    Intrahepatic ductal dilation (focal involving the left hepatic lobe)
    Beschreibung

    Intrahepatic ductal dilation, left lobe

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0545796
    UMLS CUI [1,2]
    C0012359
    UMLS CUI [1,3]
    C0227486
    UMLS CUI [1,4]
    C2711860
    lntrahepatic ductal dilation (involving both right and left hepatic lobes)
    Beschreibung

    lntrahepatic ductal dilation, both lobes

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0545796
    UMLS CUI [1,2]
    C0012359
    UMLS CUI [1,3]
    C0227486
    UMLS CUI [2,1]
    C0545796
    UMLS CUI [2,2]
    C0012359
    UMLS CUI [2,3]
    C0227481
    Extrahepatic ductal dilation
    Beschreibung

    Extrahepatic ductal dilation

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012359
    UMLS CUI [1,2]
    C2711860
    UMLS CUI [1,3]
    C0206187
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
    Beschreibung

    Diffuse ductal dilation

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0940779
    UMLS CUI [1,2]
    C2711860
    Acute Cholangitis
    Beschreibung

    Acute Cholangitis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0267917
    UMLS CUI [1,2]
    C2711860
    Primary sclerosing cholangitis
    Beschreibung

    Primary sclerosing cholangitis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0566602
    UMLS CUI [1,2]
    C2711860
    Choledocholithiasis (gallstone in duct)
    Beschreibung

    Choledocholithiasis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0701818
    UMLS CUI [1,2]
    C2711860
    Ductal filling defect(s), other than gallstone
    Beschreibung

    Ductal filling defect(s), other than gallstone

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0940806
    UMLS CUI [1,2]
    C2711860
    Ductal wall thickening or oedema
    Beschreibung

    Ductal wall thickening or oedema

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1180044
    UMLS CUI [1,2]
    C0205400
    UMLS CUI [1,3]
    C2711860
    UMLS CUI [2,1]
    C0013604
    UMLS CUI [2,2]
    C1180044
    UMLS CUI [2,3]
    C2711860
    Choledochal cyst
    Beschreibung

    Choledochal cyst

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008340
    UMLS CUI [1,2]
    C2711860
    Ductal mass
    Beschreibung

    Ductal mass

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005400
    UMLS CUI [1,2]
    C0577559
    UMLS CUI [1,3]
    C2711860
    Extrinsic mass compressing bile duct(s)
    Beschreibung

    Extrinsic mass compressing bile duct(s)

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005400
    UMLS CUI [1,2]
    C0332459
    UMLS CUI [1,3]
    C2711860
    Other Biliary ductal lesions
    Beschreibung

    Other Biliary ductal lesions

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C2711860
    UMLS CUI [1,4]
    C0205394
    If Other Biliary ductal lesions, please specify
    Beschreibung

    Other Biliary ductal lesions specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C2711860
    UMLS CUI [1,4]
    C0205394
    Portal/Hepatic vein abnormalities?
    Beschreibung

    Portal/Hepatic vein abnormalities?

    Alias
    UMLS CUI-1
    C0019155
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0032718
    UMLS CUI-4
    C1704258
    None Portal/Hepatic vein abnormalities
    Beschreibung

    None Portal/Hepatic vein abnormalities

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0549184
    UMLS CUI [1,2]
    C0019155
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [2,1]
    C0549184
    UMLS CUI [2,2]
    C0032718
    UMLS CUI [2,3]
    C1704258
    Portal vein enlargement
    Beschreibung

    Portal vein enlargement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032718
    UMLS CUI [1,2]
    C0700124
    Hepatic vein enlargement
    Beschreibung

    Hepatic vein enlargement

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C0700124
    Nonocclusive portal vein thrombosis
    Beschreibung

    Nonocclusive portal vein thrombosis

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0155773
    UMLS CUI [1,2]
    C0333204
    Occlusive portal vein thrombosis - bland
    Beschreibung

    Occlusive portal vein thrombosis - bland

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0155773
    UMLS CUI [1,2]
    C1947917
    Hepatic vein thrombosis - bland
    Beschreibung

    Hepatic vein thrombosis - bland

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019154
    Occlusive portal vein thrombosis - malignant
    Beschreibung

    Occlusive portal vein thrombosis - malignant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0155773
    UMLS CUI [1,2]
    C0205282
    Hepatic vein thrombosis - malignant
    Beschreibung

    Hepatic vein thrombosis - malignant

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0019154
    UMLS CUI [1,2]
    C0205282
    Involvement of the main portal vein
    Beschreibung

    Involvement of the main portal vein

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392760
    UMLS CUI [1,2]
    C1183135
    Involvement of the right portal vein
    Beschreibung

    Involvement of the right portal vein

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392760
    UMLS CUI [1,2]
    C0205090
    UMLS CUI [1,3]
    C0032718
    Involvement of the left portal vein
    Beschreibung

    Involvement of the left portal vein

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0392760
    UMLS CUI [1,2]
    C0205091
    UMLS CUI [1,3]
    C0032718
    Budd-Chiari syndrome
    Beschreibung

    Budd-Chiari syndrome

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0856761
    Other Portal/Hepatic vein abnormalities
    Beschreibung

    Other Portal/Hepatic vein abnormalities

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0019155
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C0032718
    UMLS CUI [2,3]
    C1704258
    If Other Portal/Hepatic vein abnormalities, please specify
    Beschreibung

    Other Portal/Hepatic vein abnormalities specification

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0019155
    UMLS CUI [1,3]
    C1704258
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C0032718
    UMLS CUI [2,3]
    C1704258
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    Ähnliche Modelle

    Liver Imaging

    1 Formulare
    1. StudyEvent: ODM
      1. Liver Imaging
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    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 Group
    What method was used for this imaging test?
    C2711860 (UMLS CUI-1)
    C0871511 (UMLS CUI-2)
    Item
    Method
    text
    C0871511 (UMLS CUI [1])
    Method
    Code List
    Method
    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/Computed Tomography (PET/CT) (7)
    CL Item
    Other (OT)
    Other method
    Item
    If other method, please specify
    text
    C0871511 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Are images technically adequate?
    C0806487 (UMLS CUI-1)
    Item
    Image quality
    text
    C0806487 (UMLS CUI [1])
    Image quality
    Code List
    Image quality
    CL Item
    Optimal (1)
    CL Item
    Readable, but not optimal  (2)
    CL Item
    Not readable (3)
    CL Item
    Other (OT)
    Other quality appearance
    Item
    If Other quality appearance, please specify
    text
    C0806487 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Indicate the liver size
    C0426688 (UMLS CUI-1)
    Item
    Liver size
    text
    C0426688 (UMLS CUI [1])
    Liver size
    Code List
    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 (A99)
    Other liver size
    Item
    If Other liver size, please specify
    text
    C0426688 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Indicate the liver texture
    C0679033 (UMLS CUI-1)
    C0023884 (UMLS CUI-2)
    Item
    Liver texture
    text
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    Liver texture
    Code List
    Liver texture
    CL Item
    Normal  (B1)
    CL Item
    Heterogeneous (B2)
    CL Item
    Suggestive of fibrosis (B3)
    CL Item
    Nodular or suggestive of cirrhosis (B4)
    CL Item
    Other (B99)
    Other liver texture
    Item
    If Other liver texture, please specify
    text
    C0679033 (UMLS CUI [1,1])
    C0023884 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Item Group
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    C0015695 (UMLS CUI-1)
    C0205219 (UMLS CUI-2)
    C0015695 (UMLS CUI-3)
    C1517526 (UMLS CUI-4)
    Item
    Diffuse and/or geographic fatty infiltrate of liver
    text
    C0015695 (UMLS CUI [1,1])
    C0205219 (UMLS CUI [1,2])
    C0015695 (UMLS CUI [2,1])
    C1517526 (UMLS CUI [2,2])
    Diffuse and/or geographic fatty infiltrate of liver
    Code List
    Diffuse and/or geographic fatty infiltrate of 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 (C99)
    Other diffuse and/or geographic fatty infiltrate of liver
    Item
    If Other diffuse and/or geographic fatty infiltrate of liver, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0015695 (UMLS CUI [1,2])
    C0205219 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2,1])
    C0015695 (UMLS CUI [2,2])
    C1517526 (UMLS CUI [2,3])
    Item Group
    Ascites present
    C0003962 (UMLS CUI-1)
    Item
    Ascites status
    text
    C0003962 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Ascites status
    Code List
    Ascites status
    CL Item
    None present (D1)
    CL Item
    Yes - small amount (D2)
    CL Item
    Yes - moderate or severe amount (D3)
    CL Item
    Other (D99)
    Other ascites status
    Item
    If Other ascites status, please specify
    text
    C0003962 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Item Group
    Are Focal Hepatic Lesions characterisable?
    C0577053 (UMLS CUI-1)
    C0205234 (UMLS CUI-2)
    Focal hepatic lesions: Not applicable - no hepatic lesions
    Item
    Focal hepatic lesions: Not applicable - no hepatic lesions
    boolean
    C1272460 (UMLS CUI [1])
    C0577053 (UMLS CUI [2,1])
    C0205234 (UMLS CUI [2,2])
    C1298908 (UMLS CUI [2,3])
    Focal hepatic lesions: Solid
    Item
    Focal hepatic lesions: Solid
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205208 (UMLS CUI [1,3])
    Focal hepatic lesions: Cystic
    Item
    Focal hepatic lesions: Cystic
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205207 (UMLS CUI [1,3])
    Focal hepatic lesions: Hemangioma
    Item
    Focal hepatic lesions: Hemangioma
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0018916 (UMLS CUI [1,3])
    Focal hepatic lesions: Focal Nodular Hyperplasia
    Item
    Focal hepatic lesions: Focal Nodular Hyperplasia
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0020510 (UMLS CUI [1,3])
    Focal hepatic lesions: Other
    Item
    Focal hepatic lesions: Other
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    Focal hepatic lesions: Other, 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])
    Item Group
    Gallstones or gallbladder lesions
    C3842395 (UMLS CUI-1)
    C0221198 (UMLS CUI-2)
    No Gallstones or gallbladder lesions
    Item
    No Gallstones or gallbladder lesions
    boolean
    C1298908 (UMLS CUI [1,1])
    C3842395 (UMLS CUI [1,2])
    C1298908 (UMLS CUI [2,1])
    C0221198 (UMLS CUI [2,2])
    Gallstones
    Item
    Gallstones
    boolean
    C0008350 (UMLS CUI [1])
    Gallbladder polyps
    Item
    Gallbladder polyp(s)
    boolean
    C0262493 (UMLS CUI [1])
    Sludge
    Item
    Sludge
    boolean
    C0860209 (UMLS CUI [1])
    Gallbladder wall thickening/oedema
    Item
    Gallbladder wall thickening/oedema
    boolean
    C0744257 (UMLS CUI [1])
    C0734014 (UMLS CUI [2,1])
    C0013604 (UMLS CUI [2,2])
    Gallbladder wall gas
    Item
    Gallbladder wall gas
    boolean
    C2246573 (UMLS CUI [1,1])
    C0016976 (UMLS CUI [1,2])
    Cholecystitis
    Item
    Cholecystitis
    boolean
    C0008325 (UMLS CUI [1])
    Gallbladder wall calcification
    Item
    Gallbladder wall calcification
    boolean
    C0016976 (UMLS CUI [1,1])
    C1533591 (UMLS CUI [1,2])
    Gallbladder mass
    Item
    Gallbladder mass
    boolean
    C0016976 (UMLS CUI [1,1])
    C0577559 (UMLS CUI [1,2])
    Other gallbladder lesions
    Item
    Other gallbladder lesions
    boolean
    C0156213 (UMLS CUI [1])
    Other gallbladder lesions specification
    Item
    If Other gallbladder lesions, please specify
    text
    C0156213 (UMLS CUI [1])
    Item Group
    Biliary ductal lesions
    C0005423 (UMLS CUI-1)
    C0221198 (UMLS CUI-2)
    C2711860 (UMLS CUI-3)
    No Biliary ductal lesions
    Item
    No Biliary ductal lesions
    boolean
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    C1298908 (UMLS CUI [1,4])
    Intrahepatic ductal dilation, right lobe
    Item
    Intrahepatic ductal dilation (focal involving the right hepatic lobe)
    boolean
    C0545796 (UMLS CUI [1,1])
    C0012359 (UMLS CUI [1,2])
    C0227481 (UMLS CUI [1,3])
    C2711860 (UMLS CUI [1,4])
    Intrahepatic ductal dilation, left lobe
    Item
    Intrahepatic ductal dilation (focal involving the left hepatic lobe)
    boolean
    C0545796 (UMLS CUI [1,1])
    C0012359 (UMLS CUI [1,2])
    C0227486 (UMLS CUI [1,3])
    C2711860 (UMLS CUI [1,4])
    lntrahepatic ductal dilation, both lobes
    Item
    lntrahepatic ductal dilation (involving both right and left hepatic lobes)
    boolean
    C0545796 (UMLS CUI [1,1])
    C0012359 (UMLS CUI [1,2])
    C0227486 (UMLS CUI [1,3])
    C0545796 (UMLS CUI [2,1])
    C0012359 (UMLS CUI [2,2])
    C0227481 (UMLS CUI [2,3])
    Extrahepatic ductal dilation
    Item
    Extrahepatic ductal dilation
    boolean
    C0012359 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    C0206187 (UMLS CUI [1,3])
    Diffuse ductal dilation
    Item
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
    boolean
    C0940779 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Acute Cholangitis
    Item
    Acute Cholangitis
    boolean
    C0267917 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Primary sclerosing cholangitis
    Item
    Primary sclerosing cholangitis
    boolean
    C0566602 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Choledocholithiasis
    Item
    Choledocholithiasis (gallstone in duct)
    boolean
    C0701818 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Ductal filling defect(s), other than gallstone
    Item
    Ductal filling defect(s), other than gallstone
    boolean
    C0940806 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Ductal wall thickening or oedema
    Item
    Ductal wall thickening or oedema
    boolean
    C1180044 (UMLS CUI [1,1])
    C0205400 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    C0013604 (UMLS CUI [2,1])
    C1180044 (UMLS CUI [2,2])
    C2711860 (UMLS CUI [2,3])
    Choledochal cyst
    Item
    Choledochal cyst
    boolean
    C0008340 (UMLS CUI [1,1])
    C2711860 (UMLS CUI [1,2])
    Ductal mass
    Item
    Ductal mass
    boolean
    C0005400 (UMLS CUI [1,1])
    C0577559 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    Extrinsic mass compressing bile duct(s)
    Item
    Extrinsic mass compressing bile duct(s)
    boolean
    C0005400 (UMLS CUI [1,1])
    C0332459 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    Other Biliary ductal lesions
    Item
    Other Biliary ductal lesions
    boolean
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Other Biliary ductal lesions specification
    Item
    If Other Biliary ductal lesions, please specify
    text
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C2711860 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [1,4])
    Item Group
    Portal/Hepatic vein abnormalities?
    C0019155 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0032718 (UMLS CUI-3)
    C1704258 (UMLS CUI-4)
    None Portal/Hepatic vein abnormalities
    Item
    None Portal/Hepatic vein abnormalities
    boolean
    C0549184 (UMLS CUI [1,1])
    C0019155 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0549184 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    C1704258 (UMLS CUI [2,3])
    Portal vein enlargement
    Item
    Portal vein enlargement
    boolean
    C0032718 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    Hepatic vein enlargement
    Item
    Hepatic vein enlargement
    boolean
    C0019155 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    Nonocclusive portal vein thrombosis
    Item
    Nonocclusive portal vein thrombosis
    boolean
    C0155773 (UMLS CUI [1,1])
    C0333204 (UMLS CUI [1,2])
    Occlusive portal vein thrombosis - bland
    Item
    Occlusive portal vein thrombosis - bland
    boolean
    C0155773 (UMLS CUI [1,1])
    C1947917 (UMLS CUI [1,2])
    Hepatic vein thrombosis - bland
    Item
    Hepatic vein thrombosis - bland
    boolean
    C0019154 (UMLS CUI [1])
    Occlusive portal vein thrombosis - malignant
    Item
    Occlusive portal vein thrombosis - malignant
    boolean
    C0155773 (UMLS CUI [1,1])
    C0205282 (UMLS CUI [1,2])
    Hepatic vein thrombosis - malignant
    Item
    Hepatic vein thrombosis - malignant
    boolean
    C0019154 (UMLS CUI [1,1])
    C0205282 (UMLS CUI [1,2])
    Involvement of the main portal vein
    Item
    Involvement of the main portal vein
    boolean
    C0392760 (UMLS CUI [1,1])
    C1183135 (UMLS CUI [1,2])
    Involvement of the right portal vein
    Item
    Involvement of the right portal vein
    boolean
    C0392760 (UMLS CUI [1,1])
    C0205090 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [1,3])
    Involvement of the left portal vein
    Item
    Involvement of the left portal vein
    boolean
    C0392760 (UMLS CUI [1,1])
    C0205091 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [1,3])
    Budd-Chiari syndrome
    Item
    Budd-Chiari syndrome
    boolean
    C0856761 (UMLS CUI [1])
    Other Portal/Hepatic vein abnormalities
    Item
    Other Portal/Hepatic vein abnormalities
    boolean
    C0205394 (UMLS CUI [1,1])
    C0019155 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    C1704258 (UMLS CUI [2,3])
    Other Portal/Hepatic vein abnormalities specification
    Item
    If Other Portal/Hepatic vein abnormalities, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C0019155 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2,1])
    C0032718 (UMLS CUI [2,2])
    C1704258 (UMLS CUI [2,3])
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