ID

38578

Beschrijving

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

Trefwoorden

Versies (1)
  1. 24-10-19 24-10-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

24 oktober 2019

DOI

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Licentie

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

Engels

Liver Imaging

1 Formulieren  
  1. StudyEvent: ODM
    1. Liver Imaging
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Liver imaging
Beschrijving

Liver imaging

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

day month year

Datatype

date

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

What method was used for this imaging test?

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

Method

Datatype

text

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

Other method

Datatype

text

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

Are images technically adequate?

Alias
UMLS CUI-1
C0806487
Image quality
Beschrijving

Image quality

Datatype

text

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

Other quality appearance

Datatype

text

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

Indicate the liver size

Alias
UMLS CUI-1
C0426688
Liver size
Beschrijving

Liver size

Datatype

text

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

Other liver size

Datatype

text

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

Indicate the liver texture

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

Liver texture

Datatype

text

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

Other liver texture

Datatype

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
Beschrijving

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
Beschrijving

Diffuse and/or geographic fatty infiltrate of liver

Datatype

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
Beschrijving

Other diffuse and/or geographic fatty infiltrate of liver

Datatype

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
Beschrijving

Ascites present

Alias
UMLS CUI-1
C0003962
Ascites status
Beschrijving

Ascites status

Datatype

text

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

Other ascites status

Datatype

text

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

Are Focal Hepatic Lesions characterisable?

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

Focal hepatic lesions: Not applicable - no hepatic lesions

Datatype

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
Beschrijving

Focal hepatic lesions: Solid

Datatype

boolean

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

Focal hepatic lesions: Cystic

Datatype

boolean

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

Focal hepatic lesions: Hemangioma

Datatype

boolean

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

Focal hepatic lesions: Focal Nodular Hyperplasia

Datatype

boolean

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

Focal hepatic lesions: Other

Datatype

boolean

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

Focal hepatic lesions: Other, specify

Datatype

text

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

Gallstones or gallbladder lesions

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

No Gallstones or gallbladder lesions

Datatype

boolean

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

Gallstones

Datatype

boolean

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

Gallbladder polyps

Datatype

boolean

Alias
UMLS CUI [1]
C0262493
Sludge
Beschrijving

Sludge

Datatype

boolean

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

Gallbladder wall thickening/oedema

Datatype

boolean

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

Gallbladder wall gas

Datatype

boolean

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

Cholecystitis

Datatype

boolean

Alias
UMLS CUI [1]
C0008325
Gallbladder wall calcification
Beschrijving

Gallbladder wall calcification

Datatype

boolean

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

Gallbladder mass

Datatype

boolean

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

Other gallbladder lesions

Datatype

boolean

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

Other gallbladder lesions specification

Datatype

text

Alias
UMLS CUI [1]
C0156213
Biliary ductal lesions
Beschrijving

Biliary ductal lesions

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

No Biliary ductal lesions

Datatype

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)
Beschrijving

Intrahepatic ductal dilation, right lobe

Datatype

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)
Beschrijving

Intrahepatic ductal dilation, left lobe

Datatype

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)
Beschrijving

lntrahepatic ductal dilation, both lobes

Datatype

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
Beschrijving

Extrahepatic ductal dilation

Datatype

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)
Beschrijving

Diffuse ductal dilation

Datatype

boolean

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

Acute Cholangitis

Datatype

boolean

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

Primary sclerosing cholangitis

Datatype

boolean

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

Choledocholithiasis

Datatype

boolean

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

Ductal filling defect(s), other than gallstone

Datatype

boolean

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

Ductal wall thickening or oedema

Datatype

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
Beschrijving

Choledochal cyst

Datatype

boolean

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

Ductal mass

Datatype

boolean

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

Extrinsic mass compressing bile duct(s)

Datatype

boolean

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

Other Biliary ductal lesions

Datatype

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
Beschrijving

Other Biliary ductal lesions specification

Datatype

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?
Beschrijving

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
Beschrijving

None Portal/Hepatic vein abnormalities

Datatype

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
Beschrijving

Portal vein enlargement

Datatype

boolean

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

Hepatic vein enlargement

Datatype

boolean

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

Nonocclusive portal vein thrombosis

Datatype

boolean

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

Occlusive portal vein thrombosis - bland

Datatype

boolean

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

Hepatic vein thrombosis - bland

Datatype

boolean

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

Occlusive portal vein thrombosis - malignant

Datatype

boolean

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

Hepatic vein thrombosis - malignant

Datatype

boolean

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

Involvement of the main portal vein

Datatype

boolean

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

Involvement of the right portal vein

Datatype

boolean

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

Involvement of the left portal vein

Datatype

boolean

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

Budd-Chiari syndrome

Datatype

boolean

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

Other Portal/Hepatic vein abnormalities

Datatype

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
Beschrijving

Other Portal/Hepatic vein abnormalities specification

Datatype

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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Similar models

Liver Imaging

1 Formulieren
  1. StudyEvent: ODM
    1. Liver Imaging
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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