ID

38915

Beschreibung

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. 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/NCT01476046

Stichworte

Versionen (2)
  1. 26.10.19 26.10.19 -
  2. 12.11.19 12.11.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

12. November 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

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

integer

Alias
UMLS CUI [1]
C2348585
Liver Imaging Number
Beschreibung

Liver Imaging Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0600091
Date of hepatic or liver imaging test
Beschreibung

Date of liver imaging

Datentyp

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
Liver imaging - General
Beschreibung

Liver imaging - General

Alias
UMLS CUI-1
C2711860
What method was used for this imaging test?
Beschreibung

if other, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Specify other method used for this imaging test
Beschreibung

Specify other liver imaging method

Datentyp

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?
Beschreibung

if other, specify

Datentyp

text

Alias
UMLS CUI [1]
C0806487
Other, specify
Beschreibung

Specify other image quality

Datentyp

text

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

If other, specify

Datentyp

text

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

Specify other liver size

Datentyp

text

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

If other, specify

Datentyp

text

Alias
UMLS CUI [1]
C1285481
Other liver texture, specify
Beschreibung

Specify other liver texture

Datentyp

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
Beschreibung

if other, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
Other diffuse and/or geographic fatty infiltrate of the liver, specify
Beschreibung

Specify other diffuse and/or geographic fatty infiltrate of the liver

Datentyp

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
Beschreibung

if other, specify

Datentyp

text

Alias
UMLS CUI [1]
C0003962
Other ascites, specify
Beschreibung

Specify other ascites

Datentyp

text

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

Are Focal Hepatic Lesions characterisable?

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

If characterisable, check all that apply in next questions

Datentyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
Solid
Beschreibung

if applicable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205208
Cystic
Beschreibung

if applicable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205207
Hemangioma
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0020510
Other Focal Hepatic Lesions, specify
Beschreibung

if applicable please specify

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
Other Focal Hepatic Lesions, specify
Beschreibung

if applicable

Datentyp

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?
Beschreibung

Gallstones or gallbladder lesions?

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

If present, check all that apply in next questions

Datentyp

text

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C0262493
Sludge
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C0008325
Gallbladder wall calcification
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C3874422
Other gallstones or gallbladder lesions, specify
Beschreibung

if applicable please specify

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0008350
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0016976
UMLS CUI [2,3]
C0221198
Other gallstones or gallbladder lesions, specify
Beschreibung

if applicable

Datentyp

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?
Beschreibung

Biliary ductal lesions?

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

If present, check all that apply in next questions

Datentyp

text

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

if applicable

Datentyp

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)
Beschreibung

if applicable

Datentyp

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)
Beschreibung

if applicable

Datentyp

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
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C0267917
Primary sclerosing cholangitis
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

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
Beschreibung

if applicable

Datentyp

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
Beschreibung

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C0008340
Ductal mass
Beschreibung

if applicable

Datentyp

boolean

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

if applicable

Datentyp

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, specify
Beschreibung

if applicable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
Other biliary ductal lesions, specify
Beschreibung

if applicable

Datentyp

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?
Beschreibung

Portal/Hepatic vein abnormalities?

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

If present, check all that apply in next questions

Datentyp

text

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

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

if applicable

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

if applicable

Datentyp

boolean

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

if applicable

Datentyp

boolean

Alias
UMLS CUI [1]
C0856761
Other portal/hepatic vein abnormalities, specify
Beschreibung

if applicable please specify

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
Other portal/hepatic vein abnormalities, specify
Beschreibung

if applicable

Datentyp

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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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
integer
C2348585 (UMLS CUI [1])
Liver Imaging Number
Item
Liver Imaging Number
integer
C2711860 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of liver imaging
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Liver imaging - General
C2711860 (UMLS CUI-1)
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 liver imaging method
Item
Specify other method used for this imaging test
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
Other, 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
Other liver size, specify
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture
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
Other liver texture, 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
Other diffuse and/or geographic fatty infiltrate of the liver, 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
Other ascites, 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)
Item
Are Focal Hepatic Lesions characterisable?
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Focal Hepatic Lesions
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
CL Item
Check all that apply (E)
Solid Focal Hepatic Lesion
Item
Solid
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
Cystic Focal Hepatic Lesion
Item
Cystic
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
Focal Hepatic Lesion: Hemangioma
Item
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 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, specify
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other Focal Hepatic Lesions
Item
Other Focal Hepatic Lesions, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Gallstones or gallbladder lesions?
C0008350 (UMLS CUI-1)
C0016976 (UMLS CUI-3)
C0221198 (UMLS CUI-4)
Item
Gallstones or gallbladder lesions?
text
C0008350 (UMLS CUI [1])
C0016976 (UMLS CUI [2,1])
C0221198 (UMLS CUI [2,2])
Gallstones or gallbladder lesions
Code List
Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Check all that apply (F)
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
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 gallstones or gallbladder lesion
Item
Other gallstones or gallbladder lesions, specify
boolean
C0205394 (UMLS CUI [1,1])
C0008350 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0016976 (UMLS CUI [2,2])
C0221198 (UMLS CUI [2,3])
Specify other gallstones or gallbladder lesions
Item
Other gallstones or gallbladder lesions, 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)
Item
Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions
Code List
Biliary ductal lesions?
CL Item
None (G0)
CL Item
Check all that apply (G)
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, specify
boolean
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other biliary ductal lesions
Item
Other biliary ductal lesions, 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)
Item
Portal/Hepatic vein abnormalities?
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Portal/Hepatic vein abnormalities
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Check all that apply (H)
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, specify
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
Other portal/hepatic vein abnormalities, specify
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
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