ID

44785

Beskrivning

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Record the details of any Adverse Events or exacerbations of Adverse Events on the Non-Serious Adverse Event Form or the Serious Adverse Event form. Exacerbations of Adverse Events include increases in frequency and severity. It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study. This form has to be filled out whenever / if liver imaging is performed (in case of a liver event).

Länk

https://clinicaltrials.gov/ct2/show/NCT00811733

Nyckelord

Versioner (1)
  1. 2021-11-26 2021-11-26 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 november 2021

DOI

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Licens

Creative Commons BY-NC 4.0
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GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733

Engelsk

Liver imaging

1 Formulär  
  1. StudyEvent: ODM
    1. Liver imaging
Date of hepatic or liver imaging test
Beskrivning

Date of hepatic or liver imaging test

Alias
UMLS CUI-1
C2711860
UMLS CUI-2
C0011008
1. Date of hepatic or liver imaging test
Beskrivning

Date of hepatic or liver imaging test

Datatyp

date

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

What method was used for this imaging test?

Alias
UMLS CUI-1
C1275506
2. What method was used for this imaging test?
Beskrivning

method used for imaging test

Datatyp

text

Alias
UMLS CUI [1]
C1275506
Other, specify:
Beskrivning

other method used for imaging test

Datatyp

text

Alias
UMLS CUI [1,1]
C1275506
UMLS CUI [1,2]
C3845569
Are images technically adequate?
Beskrivning

Are images technically adequate?

Alias
UMLS CUI-1
C0806487
UMLS CUI-2
C0205410
3. Are images technically adequate?
Beskrivning

images technically adequate

Datatyp

text

Alias
UMLS CUI [1,1]
C0806487
UMLS CUI [1,2]
C0205410
Other, specify:
Beskrivning

images technically adequate other

Datatyp

text

Alias
UMLS CUI [1,1]
C0806487
UMLS CUI [1,2]
C3845569
Indicate the liver size
Beskrivning

Indicate the liver size

Alias
UMLS CUI-1
C0426688
4. Indicate the liver size
Beskrivning

liver size

Datatyp

text

Alias
UMLS CUI [1]
C0426688
Other, specify:
Beskrivning

other liver size

Datatyp

text

Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C3845569
Indicate the liver texture
Beskrivning

Indicate the liver texture

Alias
UMLS CUI-1
C0679033
UMLS CUI-2
C0023884
5. Indicate the liver texture
Beskrivning

liver texture

Datatyp

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
Other, specify:
Beskrivning

other liver texture

Datatyp

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C3845569
Grade the diffuse and/or geographic fatty infiltrate of the liver
Beskrivning

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

Alias
UMLS CUI-1
C0015695
UMLS CUI-2
C0205219
UMLS CUI-3
C1517526
UMLS CUI-4
C0332448
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
Beskrivning

diffuse and/or geographic fatty infiltrate of the liver

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0332448
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C0332448
Other, specify
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C3845569
UMLS CUI [1,4]
C0332448
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C3845569
UMLS CUI [2,4]
C0332448
Ascites present
Beskrivning

Ascites present

Alias
UMLS CUI-1
C0003962
7. Ascites present
Beskrivning

Ascites present

Datatyp

text

Alias
UMLS CUI [1]
C0003962
Other, specify:
Beskrivning

ascites present other amount

Datatyp

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C3845569
Are Focal Hepatic Lesions characterisable?
Beskrivning

Are Focal Hepatic Lesions characterisable?

Alias
UMLS CUI-1
C0577053
UMLS CUI-2
C0205234
UMLS CUI-3
C1880022
8. Are Focal Hepatic Lesions characterisable?
Beskrivning

Focal Hepatic Lesions characterisable

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C1880022
[E1] Solid
Beskrivning

Solid Focal Hepatic Lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205208
[E2] Cystic
Beskrivning

Cystic Focal Hepatic Lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205207
[E3] Hemangioma
Beskrivning

Hemangioma Focal Hepatic Lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0018916
[E4] Focal Nodular Hyperplasia
Beskrivning

Focal Nodular Hyperplasia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0020510
[E99] Other
Beskrivning

Other Focal Hepatic Lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
Other, specify:
Beskrivning

Other Focal Hepatic Lesions specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C3845569
Gallstones or gallbladder lesions?
Beskrivning

Gallstones or gallbladder lesions?

Alias
UMLS CUI-1
C3842395
9. Gallstones or gallbladder lesions?
Beskrivning

Gallstones or gallbladder lesions

Datatyp

text

Alias
UMLS CUI [1]
C3842395
[F1] Gallstones
Beskrivning

Gallstones

Datatyp

boolean

Alias
UMLS CUI [1]
C0008350
[F2] Gallbladder polyp(s)
Beskrivning

Gallbladder polyps

Datatyp

boolean

Alias
UMLS CUI [1]
C0262493
[F3] Sludge
Beskrivning

Sludge

Datatyp

boolean

Alias
UMLS CUI [1]
C0860209
[F4] Gallbladder wall thickening/oedema
Beskrivning

Gallbladder wall thickening/oedema

Datatyp

boolean

Alias
UMLS CUI [1]
C0744257
UMLS CUI [2,1]
C0734014
UMLS CUI [2,2]
C0013604
[F5] Gallbladder wall gas
Beskrivning

Gallbladder wall gas

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0734014
UMLS CUI [1,2]
C0333139
[F6] Cholecystitis
Beskrivning

Cholecystitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0008325
[F7] Gallbladder wall calcification
Beskrivning

Gallbladder wall calcification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0734014
UMLS CUI [1,2]
C1533591
[F8] Gallbladder mass
Beskrivning

Gallbladder mass

Datatyp

boolean

Alias
UMLS CUI [1]
C3874422
[F99] Other
Beskrivning

Other gallbladder lesions

Datatyp

boolean

Alias
UMLS CUI [1]
C0156213
Other, specify
Beskrivning

Other gallbladder lesions specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0156213
UMLS CUI [1,2]
C2348235
Biliary ductal lesions?
Beskrivning

Biliary ductal lesions?

Alias
UMLS CUI-1
C0005423
UMLS CUI-2
C0221198
10. Biliary ductal lesions?
Beskrivning

Biliary ductal lesions

Datatyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
Beskrivning

Intrahepatic ductal dilation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0012359
UMLS CUI [1,3]
C0227481
[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
Beskrivning

Intrahepatic ductal dilation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0012359
UMLS CUI [1,3]
C0227486
[G3] Intrahepatic ductal dilation (involving both right and left hepatic lobes)
Beskrivning

Intrahepatic ductal dilation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005401
UMLS CUI [1,2]
C0012359
UMLS CUI [1,3]
C0227486
UMLS CUI [1,4]
C0227481
[G4] Extrahepatic ductal dilation
Beskrivning

Extrahepatic ductal dilation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0206187
UMLS CUI [1,2]
C0012359
[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
Beskrivning

Diffuse ductal dilation

Datatyp

boolean

Alias
UMLS CUI [1]
C0940779
[G6] Acute Cholangitis
Beskrivning

Acute Cholangitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0267917
[G7] Primary sclerosing cholangitis
Beskrivning

Primary sclerosing cholangitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0566602
[G8] Choledocholithiasis (gallstone in duct)
Beskrivning

Choledocholithiasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0701818
[G9] Ductal filling defect(s), other than gallstone
Beskrivning

Ductal filling defect other than gallstone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1512083
UMLS CUI [1,2]
C0332555
UMLS CUI [1,3]
C1705847
UMLS CUI [1,4]
C0242216
[G10] Ductal wall thickening or oedema
Beskrivning

Ductal wall thickening or oedema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1180044
UMLS CUI [1,2]
C0205400
UMLS CUI [2,1]
C1180044
UMLS CUI [2,2]
C0013604
[G11] Choledochal cyst
Beskrivning

Choledochal cyst

Datatyp

boolean

Alias
UMLS CUI [1]
C0008340
[G12] Ductal mass
Beskrivning

Ductal mass

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0577559
[G13] Extrinsic mass compressing bile duct(s)
Beskrivning

Extrinsic mass compressing bile duct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205101
UMLS CUI [1,2]
C0577559
UMLS CUI [1,3]
C0332260
UMLS CUI [1,4]
C0005400
[G99] Other
Beskrivning

Other Biliary ductal lesions

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
Other, specify:
Beskrivning

Other Biliary ductal lesions specification

Datatyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C3845569
Portal/Hepatic vein abnormalities?
Beskrivning

Portal/Hepatic vein abnormalities?

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

Portal/Hepatic vein abnormalities?

Datatyp

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
[H1] Portal vein enlargement
Beskrivning

Portal vein enlargement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0700124
[H2] Hepatic vein enlargement
Beskrivning

Hepatic vein enlargement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C0700124
[H3] Nonocclusive portal vein thrombosis
Beskrivning

Nonocclusive portal vein thrombosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0333204
[H4] Occlusive portal vein thrombosis - bland
Beskrivning

Occlusive portal vein thrombosis - bland

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0333203
UMLS CUI [1,3]
C1518371
[H5] Hepatic vein thrombosis - bland
Beskrivning

Hepatic vein thrombosis - bland

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019154
UMLS CUI [1,2]
C1518371
[H6] Occlusive portal vein thrombosis - malignant
Beskrivning

Occlusive portal vein thrombosis - malignant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155773
UMLS CUI [1,2]
C0333203
UMLS CUI [1,3]
C0205282
[H7] Hepatic vein thrombosis - malignant
Beskrivning

Hepatic vein thrombosis - malignant

Datatyp

text

Alias
UMLS CUI [1,1]
C0019154
UMLS CUI [1,2]
C0205282
[H8] Involvement of the main portal vein
Beskrivning

Involvement of the main portal vein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1183135
UMLS CUI [1,2]
C1314939
[H9] Involvement of the right portal vein
Beskrivning

Involvement of the right portal vein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0226730
UMLS CUI [1,2]
C1314939
[H10] Involvement of the left portal vein
Beskrivning

Involvement of the left portal vein

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0933785
UMLS CUI [1,2]
C1314939
[H11] Budd-Chiari syndrome
Beskrivning

Budd-Chiari syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0856761
[H99] Other
Beskrivning

Other Portal/Hepatic vein abnormalities

Datatyp

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, specify:
Beskrivning

Other Portal/Hepatic vein abnormalities specification

Datatyp

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0019155
UMLS CUI [1,3]
C1704258
UMLS CUI [2,1]
C3845569
UMLS CUI [2,2]
C0032718
UMLS CUI [2,3]
C1704258
Tillbaka till toppen

Similar models

Liver imaging

1 Formulär
  1. StudyEvent: ODM
    1. Liver imaging
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of hepatic or liver imaging test
C2711860 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Date of hepatic or liver imaging test
Item
1. 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?
C1275506 (UMLS CUI-1)
Item
2. What method was used for this imaging test?
text
C1275506 (UMLS CUI [1])
method used for imaging test
Code List
2. What method was used for this imaging test?
CL Item
Ultrasound - transabdominal (1)
(Comment:en)
CL Item
Ultrasound - endoscopic (2)
(Comment:en)
CL Item
Magnetic Resonance Imaging (MRI) (3)
(Comment:en)
CL Item
Computerised Tomography (CT) (4)
(Comment:en)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
(Comment:en)
CL Item
Positron Emission Tomography (PET) (6)
(Comment:en)
CL Item
Positron Emission Tomography/Computerised Tomography (PET/CT) (7)
(Comment:en)
CL Item
Other (OT)
(Comment:en)
other method used for imaging test
Item
Other, specify:
text
C1275506 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Are images technically adequate?
C0806487 (UMLS CUI-1)
C0205410 (UMLS CUI-2)
Item
3. Are images technically adequate?
text
C0806487 (UMLS CUI [1,1])
C0205410 (UMLS CUI [1,2])
images technically adequate
Code List
3. Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other (OT)
images technically adequate other
Item
Other, specify:
text
C0806487 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Indicate the liver size
C0426688 (UMLS CUI-1)
Item
4. Indicate the liver size
text
C0426688 (UMLS CUI [1])
liver size
Code List
4. Indicate the liver size
CL Item
Normal size (A1)
(Comment:en)
CL Item
Hypertrophy (or enlarged) (A2)
(Comment:en)
CL Item
Atrophy (or smaller than normal) (A3)
(Comment:en)
CL Item
Segmental hypertrophy (A4)
(Comment:en)
CL Item
Other (A99)
(Comment:en)
other liver size
Item
Other, specify:
text
C0426688 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Indicate the liver texture
C0679033 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
5. Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
liver texture
Code List
5. Indicate the liver texture
CL Item
Normal (B1)
(Comment:en)
CL Item
Heterogenous (B2)
(Comment:en)
CL Item
Suggestive of fibrosis (B3)
(Comment:en)
CL Item
Nodular or suggestive of cirrhosis (B4)
(Comment:en)
CL Item
Other, (B99)
(Comment:en)
other liver texture
Item
Other, specify:
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C3845569 (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)
C1517526 (UMLS CUI-3)
C0332448 (UMLS CUI-4)
Item
6. Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0332448 (UMLS CUI [1,3])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0332448 (UMLS CUI [2,3])
diffuse and/or geographic fatty infiltrate of the liver
Code List
6. 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 (C99)
other grade of diffuse and/or geographic fatty infiltrate of the liver
Item
Other, specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0332448 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C3845569 (UMLS CUI [2,3])
C0332448 (UMLS CUI [2,4])
Item Group
Ascites present
C0003962 (UMLS CUI-1)
Item
7. Ascites present
text
C0003962 (UMLS CUI [1])
Ascites present
Code List
7. Ascites present
CL Item
None present (D1)
CL Item
Yes - small amount (D2)
CL Item
Yes - moderate or severe amount (D3)
CL Item
Other (D99)
ascites present other amount
Item
Other, specify:
text
C0003962 (UMLS CUI [1,1])
C3845569 (UMLS CUI [1,2])
Item Group
Are Focal Hepatic Lesions characterisable?
C0577053 (UMLS CUI-1)
C0205234 (UMLS CUI-2)
C1880022 (UMLS CUI-3)
Item
8. Are Focal Hepatic Lesions characterisable?
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C1880022 (UMLS CUI [1,3])
Focal Hepatic Lesions characterisable
Code List
8. Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
CL Item
Check all that apply (E)
Solid Focal Hepatic Lesions
Item
[E1] Solid
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205208 (UMLS CUI [1,3])
Cystic Focal Hepatic Lesions
Item
[E2] Cystic
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205207 (UMLS CUI [1,3])
Hemangioma Focal Hepatic Lesions
Item
[E3] Hemangioma
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0018916 (UMLS CUI [1,3])
Focal Nodular Hyperplasia
Item
[E4] Focal Nodular Hyperplasia
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0020510 (UMLS CUI [1,3])
Other Focal Hepatic Lesions
Item
[E99] Other
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other Focal Hepatic Lesions specification
Item
Other, specify:
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Gallstones or gallbladder lesions?
C3842395 (UMLS CUI-1)
Item
9. Gallstones or gallbladder lesions?
text
C3842395 (UMLS CUI [1])
Gallstones or gallbladder lesions
Code List
9. Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Check all that apply (F)
Gallstones
Item
[F1] Gallstones
boolean
C0008350 (UMLS CUI [1])
Gallbladder polyps
Item
[F2] Gallbladder polyp(s)
boolean
C0262493 (UMLS CUI [1])
Sludge
Item
[F3] Sludge
boolean
C0860209 (UMLS CUI [1])
Gallbladder wall thickening/oedema
Item
[F4] Gallbladder wall thickening/oedema
boolean
C0744257 (UMLS CUI [1])
C0734014 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
Gallbladder wall gas
Item
[F5] Gallbladder wall gas
boolean
C0734014 (UMLS CUI [1,1])
C0333139 (UMLS CUI [1,2])
Cholecystitis
Item
[F6] Cholecystitis
boolean
C0008325 (UMLS CUI [1])
Gallbladder wall calcification
Item
[F7] Gallbladder wall calcification
boolean
C0734014 (UMLS CUI [1,1])
C1533591 (UMLS CUI [1,2])
Gallbladder mass
Item
[F8] Gallbladder mass
boolean
C3874422 (UMLS CUI [1])
Other gallbladder lesions
Item
[F99] Other
boolean
C0156213 (UMLS CUI [1])
Other gallbladder lesions specification
Item
Other, specify
text
C0156213 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Biliary ductal lesions?
C0005423 (UMLS CUI-1)
C0221198 (UMLS CUI-2)
Item
10. Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions
Code List
10. Biliary ductal lesions?
CL Item
None (G0)
CL Item
Check all that apply (G)
Intrahepatic ductal dilation
Item
[G1] Intrahepatic ductal dilation (focal involving the right hepatic lobe)
boolean
C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227481 (UMLS CUI [1,3])
Intrahepatic ductal dilation
Item
[G2] Intrahepatic ductal dilation (focal involving the left hepatic lobe)
boolean
C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
Intrahepatic ductal dilation
Item
[G3] Intrahepatic ductal dilation (involving both right and left hepatic lobes)
boolean
C0005401 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
C0227486 (UMLS CUI [1,3])
C0227481 (UMLS CUI [1,4])
Extrahepatic ductal dilation
Item
[G4] Extrahepatic ductal dilation
boolean
C0206187 (UMLS CUI [1,1])
C0012359 (UMLS CUI [1,2])
Diffuse ductal dilation
Item
[G5] Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts)
boolean
C0940779 (UMLS CUI [1])
Acute Cholangitis
Item
[G6] Acute Cholangitis
boolean
C0267917 (UMLS CUI [1])
Primary sclerosing cholangitis
Item
[G7] Primary sclerosing cholangitis
boolean
C0566602 (UMLS CUI [1])
Choledocholithiasis
Item
[G8] Choledocholithiasis (gallstone in duct)
boolean
C0701818 (UMLS CUI [1])
Ductal filling defect other than gallstone
Item
[G9] 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
[G10] Ductal wall thickening or oedema
boolean
C1180044 (UMLS CUI [1,1])
C0205400 (UMLS CUI [1,2])
C1180044 (UMLS CUI [2,1])
C0013604 (UMLS CUI [2,2])
Choledochal cyst
Item
[G11] Choledochal cyst
boolean
C0008340 (UMLS CUI [1])
Ductal mass
Item
[G12] Ductal mass
boolean
C0005423 (UMLS CUI [1,1])
C0577559 (UMLS CUI [1,2])
Extrinsic mass compressing bile duct
Item
[G13] 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
[G99] Other
boolean
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other Biliary ductal lesions specification
Item
Other, specify:
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Portal/Hepatic vein abnormalities?
C0019155 (UMLS CUI-1)
C0032718 (UMLS CUI-2)
C1704258 (UMLS CUI-3)
Item
11. 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
11. Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Check all that apply (H)
Portal vein enlargement
Item
[H1] Portal vein enlargement
boolean
C0032718 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
Hepatic vein enlargement
Item
[H2] Hepatic vein enlargement
boolean
C0019155 (UMLS CUI [1,1])
C0700124 (UMLS CUI [1,2])
Nonocclusive portal vein thrombosis
Item
[H3] Nonocclusive portal vein thrombosis
boolean
C0155773 (UMLS CUI [1,1])
C0333204 (UMLS CUI [1,2])
Occlusive portal vein thrombosis - bland
Item
[H4] Occlusive portal vein thrombosis - bland
boolean
C0155773 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C1518371 (UMLS CUI [1,3])
Hepatic vein thrombosis - bland
Item
[H5] Hepatic vein thrombosis - bland
boolean
C0019154 (UMLS CUI [1,1])
C1518371 (UMLS CUI [1,2])
Occlusive portal vein thrombosis - malignant
Item
[H6] Occlusive portal vein thrombosis - malignant
boolean
C0155773 (UMLS CUI [1,1])
C0333203 (UMLS CUI [1,2])
C0205282 (UMLS CUI [1,3])
Hepatic vein thrombosis - malignant
Item
[H7] Hepatic vein thrombosis - malignant
text
C0019154 (UMLS CUI [1,1])
C0205282 (UMLS CUI [1,2])
Involvement of the main portal vein
Item
[H8] Involvement of the main portal vein
boolean
C1183135 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Involvement of the right portal vein
Item
[H9] Involvement of the right portal vein
boolean
C0226730 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Involvement of the left portal vein
Item
[H10] Involvement of the left portal vein
boolean
C0933785 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
Budd-Chiari syndrome
Item
[H11] Budd-Chiari syndrome
boolean
C0856761 (UMLS CUI [1])
Other Portal/Hepatic vein abnormalities
Item
[H99] Other
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
Other, specify:
text
C3845569 (UMLS CUI [1,1])
C0019155 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C3845569 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C1704258 (UMLS CUI [2,3])
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