0 Ratings
ID

37412

Description

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in if liver imaging was performed as a result of an Adverse Liver Event. There are seperate forms for general information on the Adverse Liver Event and the Liver Biopsy (if performed).

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Keywords

Versions (2)
  1. 7/24/19 7/24/19 -
  2. 10/26/19 10/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    SB-681323 in ALI/ARDS risk patients - NCT00996840

    English

    Liver Events - Imaging

    1 forms  
    1. StudyEvent: ODM
      1. Liver Events - Imaging
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date/Time of Assessment
    Description

    Date/Time of Assessment

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C2985720
    UMLS CUI [1,2]
    C1264639
    Liver imaging - General
    Description

    Liver imaging - General

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

    Date of liver imaging

    Data type

    date

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

    if other, specify

    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

    specify other imaging method

    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

    if other, specify

    Data type

    text

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

    specify other image quality

    Data type

    text

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

    If other, specify

    Data type

    text

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

    specify other liver size

    Data type

    text

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

    If other, specify

    Data type

    text

    Alias
    UMLS CUI [1]
    C1285481
    If other liver texture, please specify
    Description

    specify other liver texture

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1285481
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2348235
    Grade the diffuse and/or geographic fatty infiltrate of the liver
    Description

    if other, specify

    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

    specify other 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 [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

    if other, specify

    Data type

    text

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

    specify other Ascites

    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?

    Alias
    UMLS CUI-1
    C0577053
    UMLS CUI-2
    C0205234
    Are Focal Hepatic Lesions characterisable?
    Description

    if Yes, check all that apply in next questions

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    Solid Focal Hepatic Lesion
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205208
    Cystic Focal Hepatic Lesion
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205207
    Focal Hepatic Lesion: Hemangioma
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0018916
    Focal Hepatic Lesion: Focal Nodular Hyperplasia
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0020510
    other Focal Hepatic Lesions
    Description

    if applicable please specify

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0577053
    UMLS CUI [1,2]
    C0205234
    UMLS CUI [1,3]
    C0205394
    If other Focal Hepatic Lesions, please specify
    Description

    if applicable

    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?

    Alias
    UMLS CUI-1
    C0008350
    UMLS CUI-3
    C0016976
    UMLS CUI-4
    C0221198
    Gallstones or gallbladder lesions?
    Description

    if Yes, check all that apply in next questions

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008350
    UMLS CUI [2,1]
    C0016976
    UMLS CUI [2,2]
    C0221198
    Gallstones
    Description

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262493
    Sludge
    Description

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0734014
    UMLS CUI [1,2]
    C0333139
    Cholecystitis
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008325
    Gallbladder wall calcification
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0734014
    UMLS CUI [1,2]
    C1533591
    Gallbladder mass
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3874422
    Other gallbladder lesion
    Description

    if applicable please specify

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0156213
    If other gallstones or gallbladder lesions, please specify
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C2348235
    UMLS CUI [1,3]
    C0008350
    UMLS CUI [2,1]
    C0205394
    UMLS CUI [2,2]
    C2348235
    UMLS CUI [2,3]
    C0016976
    UMLS CUI [2,4]
    C0221198
    Biliary ductal lesions?
    Description

    Biliary ductal lesions?

    Alias
    UMLS CUI-1
    C0005423
    UMLS CUI-2
    C0221198
    Biliary ductal lesions?
    Description

    if Yes, check all that apply in next questions

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    Intrahepatic ductal dilation (focal involving the right hepatic lobe)
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005401
    UMLS CUI [1,2]
    C0700124
    UMLS CUI [1,3]
    C0227481
    Intrahepatic ductal dilation (focal involving the left hepatic lobe)
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005401
    UMLS CUI [1,2]
    C0700124
    UMLS CUI [1,3]
    C0227486
    Intrahepatic ductal dilation (involving both right and left hepatic lobes)
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005401
    UMLS CUI [1,2]
    C0700124
    UMLS CUI [1,3]
    C0227486
    UMLS CUI [2,1]
    C0005401
    UMLS CUI [2,2]
    C0700124
    UMLS CUI [2,3]
    C0227481
    Extrahepatic ductal dilation
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0700124
    UMLS CUI [1,2]
    C0206187
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005401
    UMLS CUI [1,2]
    C0700124
    UMLS CUI [2,1]
    C0700124
    UMLS CUI [2,2]
    C0206187
    Acute Cholangitis
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0267917
    Primary sclerosing cholangitis
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0566602
    Choledocholithiasis (gallstone in duct)
    Description

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1512083
    UMLS CUI [1,2]
    C0332555
    UMLS CUI [1,3]
    C1705847
    UMLS CUI [1,4]
    C0242216
    Ductal wall thickening or oedema
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0442069
    UMLS CUI [1,3]
    C0205400
    UMLS CUI [2,1]
    C0005423
    UMLS CUI [2,2]
    C0442069
    UMLS CUI [2,3]
    C0013604
    Choledochal cyst
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008340
    Ductal mass
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0577559
    Extrinsic mass compressing bile duct(s)
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205101
    UMLS CUI [1,2]
    C0577559
    UMLS CUI [1,3]
    C0332260
    UMLS CUI [1,4]
    C0005400
    Other Biliary ductal lesions
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0005423
    UMLS CUI [1,2]
    C0221198
    UMLS CUI [1,3]
    C0205394
    If other biliary ductal lesions, please specify
    Description

    specify other biliary ductal lesions

    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?

    Alias
    UMLS CUI-1
    C0019155
    UMLS CUI-2
    C1704258
    UMLS CUI-3
    C0032718
    Portal/Hepatic vein abnormalities?
    Description

    if Yes, check all that apply in next questions

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [2,1]
    C0032718
    UMLS CUI [2,2]
    C1704258
    Portal vein enlargement
    Description

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0155773
    UMLS CUI [1,2]
    C1265798
    Hepatic vein thrombosis - bland
    Description

    if applicable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019154
    UMLS CUI [1,2]
    C1265798
    Occlusive portal vein thrombosis - malignant
    Description

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable

    Data type

    boolean

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

    if applicable please specify

    Data type

    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
    Description

    if applicable

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0019155
    UMLS CUI [1,2]
    C1704258
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    UMLS CUI [2,1]
    C0032718
    UMLS CUI [2,2]
    C1704258
    UMLS CUI [2,3]
    C0205394
    UMLS CUI [2,4]
    C2348235
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    Similar models

    Liver Events - Imaging

    1 forms
    1. StudyEvent: ODM
      1. Liver Events - Imaging
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date/Time of Assessment
    Item
    Date/Time of Assessment
    datetime
    C2985720 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    Liver imaging - General
    C2711860 (UMLS CUI-1)
    Date of liver imaging
    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 (OT)
    specify other imaging method
    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 (OT)
    specify other image quality
    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 (A99)
    specify other liver size
    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
    C1285481 (UMLS CUI [1])
    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 (B99)
    specify other liver texture
    Item
    If other liver texture, please specify
    text
    C1285481 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    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)
    specify other diffuse and/or geographic fatty infiltrate of the liver
    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)
    specify other Ascites
    Item
    If other Ascites, please specify
    text
    C0003962 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Are Focal Hepatic Lesions characterisable?
    C0577053 (UMLS CUI-1)
    C0205234 (UMLS CUI-2)
    Focal Hepatic Lesions
    Item
    Are Focal Hepatic Lesions characterisable?
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    Solid Focal Hepatic Lesion
    Item
    Solid Focal Hepatic Lesion
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205208 (UMLS CUI [1,3])
    Cystic Focal Hepatic Lesion
    Item
    Cystic Focal Hepatic Lesion
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205207 (UMLS CUI [1,3])
    Focal Hepatic Lesion: Hemangioma
    Item
    Focal Hepatic Lesion: Hemangioma
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0018916 (UMLS CUI [1,3])
    Focal Hepatic Lesion: Focal Nodular Hyperplasia
    Item
    Focal Hepatic Lesion: Focal Nodular Hyperplasia
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0020510 (UMLS CUI [1,3])
    other Focal Hepatic Lesions
    Item
    other Focal Hepatic Lesions
    boolean
    C0577053 (UMLS CUI [1,1])
    C0205234 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    specify other Focal Hepatic Lesions
    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])
    Item Group
    Gallstones or gallbladder lesions?
    C0008350 (UMLS CUI-1)
    C0016976 (UMLS CUI-3)
    C0221198 (UMLS CUI-4)
    Gallstones or gallbladder lesions
    Item
    Gallstones or gallbladder lesions?
    boolean
    C0008350 (UMLS CUI [1])
    C0016976 (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])
    C0734014 (UMLS CUI [2,2])
    Gallbladder wall gas
    Item
    Gallbladder wall gas
    boolean
    C0734014 (UMLS CUI [1,1])
    C0333139 (UMLS CUI [1,2])
    Cholecystitis
    Item
    Cholecystitis
    boolean
    C0008325 (UMLS CUI [1])
    Gallbladder wall calcification
    Item
    Gallbladder wall calcification
    boolean
    C0734014 (UMLS CUI [1,1])
    C1533591 (UMLS CUI [1,2])
    Gallbladder mass
    Item
    Gallbladder mass
    boolean
    C3874422 (UMLS CUI [1])
    Other gallbladder lesion
    Item
    Other gallbladder lesion
    boolean
    C0156213 (UMLS CUI [1])
    sepcify other gallstones or gallbladder lesions
    Item
    If other gallstones or gallbladder lesions, please specify
    text
    C0205394 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    C0008350 (UMLS CUI [1,3])
    C0205394 (UMLS CUI [2,1])
    C2348235 (UMLS CUI [2,2])
    C0016976 (UMLS CUI [2,3])
    C0221198 (UMLS CUI [2,4])
    Item Group
    Biliary ductal lesions?
    C0005423 (UMLS CUI-1)
    C0221198 (UMLS CUI-2)
    Biliary ductal lesions
    Item
    Biliary ductal lesions?
    boolean
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    Intrahepatic ductal dilation (right hepatic lobe)
    Item
    Intrahepatic ductal dilation (focal involving the right hepatic lobe)
    boolean
    C0005401 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    C0227481 (UMLS CUI [1,3])
    Intrahepatic ductal dilation (left hepatic lobe)
    Item
    Intrahepatic ductal dilation (focal involving the left hepatic lobe)
    boolean
    C0005401 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    C0227486 (UMLS CUI [1,3])
    Intrahepatic ductal dilation (right and left hepatic lobes)
    Item
    Intrahepatic ductal dilation (involving both right and left hepatic lobes)
    boolean
    C0005401 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    C0227486 (UMLS CUI [1,3])
    C0005401 (UMLS CUI [2,1])
    C0700124 (UMLS CUI [2,2])
    C0227481 (UMLS CUI [2,3])
    Extrahepatic ductal dilation
    Item
    Extrahepatic ductal dilation
    boolean
    C0700124 (UMLS CUI [1,1])
    C0206187 (UMLS CUI [1,2])
    Diffuse ductal dilation (intrahepatic and extrahepatic ducts)
    Item
    Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
    boolean
    C0005401 (UMLS CUI [1,1])
    C0700124 (UMLS CUI [1,2])
    C0700124 (UMLS CUI [2,1])
    C0206187 (UMLS CUI [2,2])
    Acute Cholangitis
    Item
    Acute Cholangitis
    boolean
    C0267917 (UMLS CUI [1])
    Primary sclerosing cholangitis
    Item
    Primary sclerosing cholangitis
    boolean
    C0566602 (UMLS CUI [1])
    Choledocholithiasis
    Item
    Choledocholithiasis (gallstone in duct)
    boolean
    C0701818 (UMLS CUI [1])
    Ductal filling defect other than gallstone
    Item
    Ductal filling defect(s), other than gallstone
    boolean
    C1512083 (UMLS CUI [1,1])
    C0332555 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [1,3])
    C0242216 (UMLS CUI [1,4])
    Ductal wall thickening or oedema
    Item
    Ductal wall thickening or oedema
    boolean
    C0005423 (UMLS CUI [1,1])
    C0442069 (UMLS CUI [1,2])
    C0205400 (UMLS CUI [1,3])
    C0005423 (UMLS CUI [2,1])
    C0442069 (UMLS CUI [2,2])
    C0013604 (UMLS CUI [2,3])
    Choledochal cyst
    Item
    Choledochal cyst
    boolean
    C0008340 (UMLS CUI [1])
    Ductal mass
    Item
    Ductal mass
    boolean
    C0005423 (UMLS CUI [1,1])
    C0577559 (UMLS CUI [1,2])
    Extrinsic mass compressing bile duct
    Item
    Extrinsic mass compressing bile duct(s)
    boolean
    C0205101 (UMLS CUI [1,1])
    C0577559 (UMLS CUI [1,2])
    C0332260 (UMLS CUI [1,3])
    C0005400 (UMLS CUI [1,4])
    Other Biliary ductal lesions
    Item
    Other Biliary ductal lesions
    boolean
    C0005423 (UMLS CUI [1,1])
    C0221198 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    specify other biliary ductal lesions
    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])
    Item Group
    Portal/Hepatic vein abnormalities?
    C0019155 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    C0032718 (UMLS CUI-3)
    Portal/Hepatic vein abnormalities
    Item
    Portal/Hepatic vein abnormalities?
    boolean
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0032718 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    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])
    C1265798 (UMLS CUI [1,2])
    Hepatic vein thrombosis - bland
    Item
    Hepatic vein thrombosis - bland
    boolean
    C0019154 (UMLS CUI [1,1])
    C1265798 (UMLS CUI [1,2])
    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])
    specify other portal/ hepatic vein abnormalities
    Item
    If other portal/ hepatic vein abnormalities, please specify
    text
    C0019155 (UMLS CUI [1,1])
    C1704258 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    C0032718 (UMLS CUI [2,1])
    C1704258 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [2,3])
    C2348235 (UMLS CUI [2,4])
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