ID

42304

Description

Study ID: 111406 Clinical Study ID: 111406 Study Title: A First-Time-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing in Healthy Volunteers using a Dose- Escalating, Randomized, Placebo-Controlled Study Design Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00721812 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Placebo, locally-acting anti-inflammatory compound GSK1399686 Study Indication: Inflammatory Bowel Diseases

Keywords

Versions (1)
  1. 5/26/21 5/26/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 26, 2021

DOI

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License

Creative Commons BY 4.0
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Safety, Tolerability and Pharmacokinetics of GSK1399686 After Single and Repeated Oral Dosing NCT00721812

English

Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Description

Centre Number

Data type

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-3
C0877248
UMLS CUI-5
C0220825
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Description

Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0008000
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C2746065
UMLS CUI [3,3]
C0243161
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Date of liver biopsy

Data type

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Description

Approximate size of liver biopsy

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
A. Final Diagnosis
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C1546485
Specify other Final Diagnosis
Description

Specify other Final Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
B. Liver Architecture
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
Specify other Liver Architecture
Description

Specify other Liver Architecture

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
C. Description of Liver or Hepatocytes
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
Specify other Liver or Hepatocytes
Description

Specify other Liver or Hepatocytes

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0205394
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0227525
UMLS CUI [2]
C0042219
UMLS CUI [3]
C1512693
Specify other Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Specify other Liver Cell or Hepatocyte Inclusions or Vacuoles

Data type

text

Alias
UMLS CUI [1]
C0227525
UMLS CUI [2]
C0042219
UMLS CUI [3]
C1512693
UMLS CUI [4]
C0205394
UMLS CUI [5]
C2348235
E. Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0227525
UMLS CUI [2,1]
C1849376
UMLS CUI [2,2]
C0193388
Specify other Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Specify other Hepatocyte or Liver Cell Nuclear Abnormalities

Data type

text

Alias
UMLS CUI [1]
C0227525
UMLS CUI [2,1]
C1849376
UMLS CUI [2,2]
C0193388
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
F. Liver or Lobular Infiltrates
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0205417
UMLS CUI [2]
C1400896
Specify other Liver or Lobular Infiltrates
Description

Specify other Liver or Lobular Infiltrates

Data type

text

Alias
UMLS CUI [1]
C0205417
UMLS CUI [2]
C1400896
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
G. Portal Tract Inflammation
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C3854488
Specify other Portal Tract Inflammation
Description

Specify other Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1]
C3854488
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
H. Bile Ducts
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0005400
Specify other Bile Ducts
Description

Specify other Bile Ducts

Data type

text

Alias
UMLS CUI [1]
C0005400
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
I. Portal Veins
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0032718
Specify other Portal Veins
Description

Specify other Portal Veins

Data type

text

Alias
UMLS CUI [1]
C0032718
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
J. Liver Infections
Description

J. Liver Infections

Data type

text

Alias
UMLS CUI [1]
C1112211
Specify other Liver Infection
Description

Specify other Liver Infection

Data type

text

Alias
UMLS CUI [1]
C1112211
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
K. Parasites or Ova
Description

K. Parasites or Ova

Data type

text

Alias
UMLS CUI [1]
C0030498
UMLS CUI [2]
C0555117
Specify other Parasites or Ova
Description

Specify other Parasites or Ova

Data type

text

Alias
UMLS CUI [1]
C0030498
UMLS CUI [2]
C0555117
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
L. Histologic Staining or Additional Studies Obtained
Description

L. Histologic Staining or Additional Studies Obtained

Data type

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1524062
Specify other Histologic Staining or Additional Studies Obtained
Description

Specify other Histologic Staining or Additional Studies Obtained

Data type

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1524062
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Description

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0023884
UMLS CUI [2]
C0022885
UMLS CUI [3,1]
C2746065
UMLS CUI [3,2]
C0243161
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
Description

If the liver event occurred during treatment period record start date of investigational product for that treatment period.

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0347984
UMLS CUI [4,1]
C0304229
UMLS CUI [4,2]
C0808070
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
Description

If the liver event occurred during treatment period record stop date of investigational product for that treatment period.

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0347984
UMLS CUI [4,1]
C0304229
UMLS CUI [4,2]
C0806020
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
Description

If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3]
C0304229
UMLS CUI [4]
C0808070
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Description

If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3]
C0304229
UMLS CUI [4]
C0806020
Is the subject age 55 or older?
Description

Is the subject age 55 or older?

Data type

boolean

Alias
UMLS CUI [1]
C0001779
If female, ist the subject pregnant?
Description

If female, ist the subject pregnant?

Data type

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?

Data type

boolean

Alias
UMLS CUI [1]
C0011923
UMLS CUI [2]
C1711359
UMLS CUI [3]
C0023884
UMLS CUI [4]
C1456803
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0436427
UMLS CUI [7]
C0024485
UMLS CUI [8]
C0008310
If diagnostic imaging tests have been performed, were results normal?
Description

If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Data type

boolean

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0011923
Were any liver biopsies performed?
Description

If Yes, complete Liver Biopsy form.

Data type

boolean

Alias
UMLS CUI [1]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

If Yes, record on the appropriate Concomitant Medication form.

Data type

boolean

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

Did the subject fast or undergo significant dietary change in the past week?

Data type

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2]
C3671772
Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2;).

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If Yes, date and time sample taken
Description

If Yes, date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
If Yes, date and time of last investigational product dose prior to PK sample
Description

If Yes, date and time of last investigational product dose prior to PK sample

Data type

datetime

Alias
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1762893
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0946444
Sample Identifier Label
Description

Sample Identifier Label

Data type

text

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0600091
Sample Number
Description

Sample Number

Data type

text

Alias
UMLS CUI [1]
C1299222
Alcohol Intake
Description

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Record the average number of units of alcohol1 consumed per week
Description

1 unit of alcohol in UK = 1 measure of spirits, 1/2 pint beer, 1 small glass of wine (125ml) If the subject does not drink enter '0'.

Data type

integer

Measurement units
  • units/week
Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0560579
units/week
Liver Disease Medical Conditions
Description

Liver Disease Medical Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0262926
Specific Condition
Description

Check only one response for each condition

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Drug Related Liver Disease Conditions
Description

Drug Related Liver Disease Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug Related Liver Disease Conditions
Description

Drug Related Liver Disease Conditions

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Other Liver Disease Conditions
Description

Other Liver Disease Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Specific Condition
Description

Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Other Medical Conditions
Description

Other Medical Conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Specific Condition
Description

Check only one response for each condition

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Condition Status
Description

Condition Status

Data type

integer

Alias
UMLS CUI [1]
C3176928
Liver Imaging
Description

Liver Imaging

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

Date of hepatic or liver imaging test

Data type

date

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

Check one. If more than one imaging test was performed, complete a separate form for each test).

Data type

integer

Alias
UMLS CUI [1]
C2711860
UMLS CUI [2]
C1275506
Specify other method for imaging
Description

Specify other method for imaging

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Are images technically adequate?
Description

Check one.

Data type

text

Alias
UMLS CUI [1]
C0806487
Specify other image quality
Description

Specify other image quality

Data type

text

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

Check one.

Data type

text

Alias
UMLS CUI [1]
C0426688
Specify other liver size
Description

Specify other liver size

Data type

text

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

Check one.

Data type

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
Specify other liver texture
Description

Specify other liver texture

Data type

text

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

Check one.

Data type

text

Alias
UMLS CUI [1]
C0015695
UMLS CUI [2]
C0205219
UMLS CUI [3]
C1517526
UMLS CUI [4]
C0332448
Specify other diffuse and/or geographic fatty infiltrate
Description

Specify other diffuse and/or geographic fatty infiltrate

Data type

text

Alias
UMLS CUI [1]
C0015695
UMLS CUI [2]
C0205219
UMLS CUI [3]
C1517526
UMLS CUI [4]
C0205394
UMLS CUI [5]
C2348235
D. Ascites present
Description

Check one

Data type

text

Alias
UMLS CUI [1]
C0003962
Specify other ascites
Description

Specify other ascites

Data type

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
E. Are Focal Hepatic Lesions characterisable?
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
Specify other focal hepatic lesion
Description

Specify other focal hepatic lesion

Data type

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
F. Gallstones or gallbladder lesions?
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
Specify other gallstones or gallbladder lesions.
Description

Specify other gallstones or gallbladder lesions.

Data type

text

Alias
UMLS CUI [1]
C3842395
UMLS CUI [2]
C0221198
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
G. Biliary ductal lesions?
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
Specify other biliary duct lesion
Description

Specify other biliary duct lesion

Data type

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
H. Portal/Hepatic vein abnormalities?
Description

Check all that apply.

Data type

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0019155
UMLS CUI [2,2]
C1704258
Specify other portal/hepatic vein abnormalities.
Description

Specify other portal/hepatic vein abnormalities.

Data type

text

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

Liver Assessment; Liver Biopsy; Liver Events; Liver Imaging

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-3)
C0220825 (UMLS CUI-5)
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0232741 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
C0304229 (UMLS CUI [3,1])
C2746065 (UMLS CUI [3,2])
C0243161 (UMLS CUI [3,3])
Item Group
Liver Biopsy
C0193388 (UMLS CUI-1)
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
float
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
A. Final Diagnosis
text
C1546485 (UMLS CUI [1])
A. Final Diagnosis
Code List
A. Final Diagnosis
CL Item
Normal (A0)
CL Item
Acute hepatitis (A1)
CL Item
Chronic hepatitis (A2)
CL Item
Cholestatic hepatitis (A3)
CL Item
Drug-induced cholestasis (A4)
CL Item
Acute viral hepatitis (A5)
CL Item
Chronic viral hepatitis (A6)
CL Item
Drug-induced hepatitis (A7)
CL Item
Autoimmune hepatitis (A8)
CL Item
Bridging necrosis (A9)
CL Item
Submassive hepatic necrosis (A10)
CL Item
Massive hepatic necrosis (A11)
CL Item
Steatosis - microvesicular (A12)
CL Item
Steatosis - macrovesicular (A13)
CL Item
Steatosis - mixed (A14)
CL Item
Non-alcoholic steatohepatitis (A15)
CL Item
Alcoholic hepatitis (A16)
CL Item
Hepatic granulomas (A17)
CL Item
Sarcoidosis (A18)
CL Item
Fibrosis (A19)
CL Item
Cirrhosis (A20)
CL Item
Primary biliary cirrhosis (A21)
CL Item
Primary sclerosing cholangitis (A22)
CL Item
Autoimmune overlap syndrome (A23)
CL Item
Hemochromatosis (A24)
CL Item
Alpha-1-antitrypsin deficiency (A25)
CL Item
Wilson’s disease (A26)
CL Item
Veno-occlusive disease (A27)
CL Item
Budd-Chiari syndrome (A28)
CL Item
Neoplasia (A29)
CL Item
Other, specify (A99)
Specify other Final Diagnosis
Item
Specify other Final Diagnosis
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
B. Liver Architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
B. Liver Architecture
Code List
B. Liver Architecture
CL Item
Normal (B1)
CL Item
Bridging fibrosis (B2)
CL Item
Diffuse fibrosis (B3)
CL Item
Nodular regenerative hyperplasia (B4)
CL Item
Congenital hepatic fibrosis (B5)
CL Item
Cirrhosis (B6)
CL Item
Centrilobular congestion (B7)
CL Item
Endophlebitis (B8)
CL Item
Veno-occlusive disease (B9)
CL Item
Canalicular cholestasis (B10)
CL Item
Apoptosis (B11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis (B12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis) (B13)
CL Item
Ischaemic necrosis (B14)
CL Item
Centrolobular (Zone 3) necrosis (B15)
CL Item
Focal coagulative necrosis (B16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (B17)
CL Item
Bridging hepatocellular necrosis (B18)
CL Item
Massive or panlobular hepatocellular necrosis (B19)
CL Item
Dysplasia (B20)
CL Item
Neoplasia (B21)
CL Item
Other, specify (B99)
Specify other Liver Architecture
Item
Specify other Liver Architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
C. Description of Liver or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C. Description of Liver or Hepatocytes
Code List
C. Description of Liver or Hepatocytes
CL Item
Normal (C0)
CL Item
Ballooning (C1)
CL Item
Acidophilic (C2)
CL Item
Pseudoxanthomatous (C3)
CL Item
Multinucleated giant hepatocytes (C4)
CL Item
Other, specify (C99)
Specify other Liver or Hepatocytes
Item
Specify other Liver or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
Code List
D. Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (D0)
CL Item
Macrovesicular steatosis (D1)
CL Item
Microvesicular steatosis (D2)
CL Item
Bile accumulation (D3)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (D4)
CL Item
Alpha-1-antitrypsin inclusions (D5)
CL Item
Megamitochondria (D6)
CL Item
Mallory bodies (D7)
CL Item
"Ground Glass" inclusions (D8)
CL Item
Lipofuscin pigment (D9)
CL Item
Hemosiderin granules (D10)
CL Item
Orcein-positive cytoplasmin granules (D11)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (D12)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (D13)
CL Item
Other, specify (D99)
Specify other Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
Specify other Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
Item
E. Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0227525 (UMLS CUI [1])
C1849376 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
E. Hepatocyte or Liver Cell Nuclear Abnormalities
Code List
E. Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (E0)
CL Item
Hepatocellular mitoses (E1)
CL Item
Binucleated or multinucleated hepatocytes (E2)
CL Item
CMV inclusion bodies (E3)
CL Item
HSV inclusions (E4)
CL Item
Varicella inclusions (E5)
CL Item
Other, specify (E99)
Specify other Hepatocyte or Liver Cell Nuclear Abnormalities
Item
Specify other Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0227525 (UMLS CUI [1])
C1849376 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
F. Liver or Lobular Infiltrates
text
C0205417 (UMLS CUI [1])
C1400896 (UMLS CUI [2])
F. Liver or Lobular Infiltrates
Code List
F. Liver or Lobular Infiltrates
CL Item
None (F0)
CL Item
Eosinophils (F1)
CL Item
Lymphocytes (F2)
CL Item
Plasma cells (F3)
CL Item
Neutrophils (F4)
CL Item
Macrophages and proliferating Kupffer cells (F5)
CL Item
Granulomas (F6)
CL Item
Other, specify (F99)
Specify other Liver or Lobular Infiltrates
Item
Specify other Liver or Lobular Infiltrates
text
C0205417 (UMLS CUI [1])
C1400896 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
G. Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
G. Portal Tract Inflammation
Code List
G. Portal Tract Inflammation
CL Item
None (G0)
CL Item
Eosinophils (G1)
CL Item
Lymphoid aggregates and/or follicles (G2)
CL Item
Plasma cells (G3)
CL Item
Neutrophils (G4)
CL Item
Histocytes and macrophages (G5)
CL Item
Other, specify (G99)
Specify other Portal Tract Inflammation
Item
Specify other Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
H. Bile Ducts
text
C0005400 (UMLS CUI [1])
H. Bile Ducts
Code List
H. Bile Ducts
CL Item
Normal (H0)
CL Item
Proliferation of bile ducts (bile ductular reaction) (H1)
CL Item
Dilation, degeneration or disruption of portal bile ducts (H2)
CL Item
Paucity of bile ducts (H3)
CL Item
Periductal fibrosis (H4)
CL Item
Other, specify (H99)
Specify other Bile Ducts
Item
Specify other Bile Ducts
text
C0005400 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
I. Portal Veins
text
C0032718 (UMLS CUI [1])
I. Portal Veins
Code List
I. Portal Veins
CL Item
Normal (I0)
CL Item
Pyelophlebitis (I1)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (I2)
CL Item
Neoplastic invasion of portal vein (I3)
CL Item
Granulomatous compression of portal vein (I4)
CL Item
Other, specif (I99)
Specify other Portal Veins
Item
Specify other Portal Veins
text
C0032718 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
J. Liver Infections
text
C1112211 (UMLS CUI [1])
J. Liver Infections
Code List
J. Liver Infections
CL Item
Normal (J0)
CL Item
Leishmaniasis donovani (J1)
CL Item
Plasmodium falciparum (J2)
CL Item
Toxoplasmosis (J3)
CL Item
Cryptococcus neoformans (J4)
CL Item
Histoplasma capsulatum (J5)
CL Item
Mycobacterium tuberculosis (J6)
CL Item
Other mycobacterial species (J7)
CL Item
Other, specify (J99)
Specify other Liver Infection
Item
Specify other Liver Infection
text
C1112211 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
K. Parasites or Ova
text
C0030498 (UMLS CUI [1])
C0555117 (UMLS CUI [2])
K. Parasites or Ova
Code List
K. Parasites or Ova
CL Item
None (K0)
CL Item
Schistosome and/or ova (K1)
CL Item
Ascaris and/or ova (K2)
CL Item
Toxocara and/or ova (K3)
CL Item
Echinococcus cysts (K4)
CL Item
Hepatic capillariasis worms and/or ova (K5)
CL Item
Other, specify (K99)
Specify other Parasites or Ova
Item
Specify other Parasites or Ova
text
C0030498 (UMLS CUI [1])
C0555117 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
L. Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
L. Histologic Staining or Additional Studies Obtained
Code List
L. Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E) (L1)
CL Item
Masson (L2)
CL Item
Toluidine blue or Giemsa (L3)
CL Item
Prussian blue (L4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (L5)
CL Item
Oil red O (L6)
CL Item
Congo red (L7)
CL Item
Hall’s stain (L8)
CL Item
Gridley’s stain (L9)
CL Item
Rhodanine (copper) (L10)
CL Item
Rubeanic acid (copper) (L11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (L12)
CL Item
Electron microscopy (L13)
CL Item
Hepatitis A immunostains positive (L14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (L15)
CL Item
Hepatitis D immunostains (L16)
CL Item
Other immunostains (L17)
CL Item
Other, specify (L99)
Specify other Histologic Staining or Additional Studies Obtained
Item
Specify other Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1])
C0022885 (UMLS CUI [2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5’ nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (OT)
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
Item
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0347984 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C0808070 (UMLS CUI [4,2])
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
Item
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
C0347984 (UMLS CUI [3])
C0304229 (UMLS CUI [4,1])
C0806020 (UMLS CUI [4,2])
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
Item
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C0808070 (UMLS CUI [4])
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Item
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3])
C0806020 (UMLS CUI [4])
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, ist the subject pregnant?
text
C0032961 (UMLS CUI [1])
If female, ist the subject pregnant?
Code List
If female, ist the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as a liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1])
C1711359 (UMLS CUI [2])
C0023884 (UMLS CUI [3])
C1456803 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0436427 (UMLS CUI [6])
C0024485 (UMLS CUI [7])
C0008310 (UMLS CUI [8])
If diagnostic imaging tests have been performed, were results normal?
Item
If diagnostic imaging tests have been performed, were results normal?
boolean
C1274040 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0281875 (UMLS CUI [5])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
If Yes, date and time sample taken
Item
If Yes, date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
If Yes, date and time of last investigational product dose prior to PK sample
Item
If Yes, date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0946444 (UMLS CUI [3,2])
Sample Identifier Label
Item
Sample Identifier Label
text
C0178913 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Sample Number
Item
Sample Number
text
C1299222 (UMLS CUI [1])
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Record the average number of units of alcohol1 consumed per week
Item
Record the average number of units of alcohol1 consumed per week
integer
C0001948 (UMLS CUI [1])
C0560579 (UMLS CUI [2])
Item Group
Liver Disease Medical Conditions
C0023895 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific Condition
Code List
Specific Condition
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug Related Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug Related Liver Disease Conditions
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug Related Liver Disease Conditions
Code List
Drug Related Liver Disease Conditions
CL Item
Drug related liver disease (14)
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current  (1)
CL Item
Past  (2)
CL Item
No Medical Condition (5)
Item Group
Other Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other Medical Conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Specific Condition
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific Condition
Code List
Specific Condition
CL Item
Drug Allergies (17)
CL Item
Rheumatoid Arthritis (18)
CL Item
Psoriasis (19)
CL Item
Thyroid Disease (20)
CL Item
Inflammatory Bowel Disease (21)
CL Item
Lupus (22)
CL Item
Sjogren’s Syndrome (23)
CL Item
Vitiligo (24)
Item
Condition Status
integer
C3176928 (UMLS CUI [1])
Condition Status
Code List
Condition Status
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
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])
C0011008 (UMLS CUI [2])
Item
What method was used for this imaging test?
integer
C2711860 (UMLS CUI [1])
C1275506 (UMLS CUI [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/Computed Tomography (PET/CT) (7)
CL Item
Other, specify (8)
Specify other method for imaging
Item
Specify other method for imaging
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
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, specify (OT)
Specify other image quality
Item
Specify other image quality
text
C0806487 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
A. Indicate the liver size
text
C0426688 (UMLS CUI [1])
A. Indicate the liver size
Code List
A. 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, specify (A99)
Specify other liver size
Item
Specify other liver size
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
B. Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
B. Indicate the liver texture
Code List
B. Indicate the liver texture
CL Item
Normal (B1)
CL Item
Heterogeneous (B2)
CL Item
Sugestive of fibrosis (B3)
CL Item
Nodular or suggestive or cirrhosis (B4)
CL Item
Other, specify (B99)
Specify other liver texture
Item
Specify other liver texture
text
C1285481 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
C. Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
C0332448 (UMLS CUI [4])
C. Grade the diffuse and/or geographic fatty infiltrate of the liver
Code List
C. 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
Item
Specify other diffuse and/or geographic fatty infiltrate
text
C0015695 (UMLS CUI [1])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
Item
D. Ascites present
text
C0003962 (UMLS CUI [1])
D. Ascites present
Code List
D. 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
Specify other ascites
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
E. Are Focal Hepatic Lesions characterisable?
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
E. Are Focal Hepatic Lesions characterisable?
Code List
E. Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
CL Item
Solid (E1)
CL Item
Cystic (E2)
CL Item
Hemangioma (E3)
CL Item
Focal Nodular Hyperplasia (E4)
CL Item
Other, specify (E99)
Specify other focal hepatic lesion
Item
Specify other focal hepatic lesion
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
F. Gallstones or gallbladder lesions?
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
F. Gallstones or gallbladder lesions?
Code List
F. Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Gallstones (F1)
CL Item
Gallbladder polyp(s) (F2)
CL Item
Sludge (F3)
CL Item
Gallbladder wall thickening/oedema (F4)
CL Item
Gallbladder wall gas (F5)
CL Item
Cholecystitis (F6)
CL Item
Gallbladder wall calcification (F7)
CL Item
Gallbladder mass (F8)
CL Item
Other, specify (F99)
Specify other gallstones or gallbladder lesions.
Item
Specify other gallstones or gallbladder lesions.
text
C3842395 (UMLS CUI [1])
C0221198 (UMLS CUI [2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
Item
G. Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
G. Biliary ductal lesions?
Code List
G. Biliary ductal lesions?
CL Item
None (G0)
CL Item
bIntrahepatic ductal dilation (focal involving the right hepatic lobe) (G1)
CL Item
Intrahepatic dutal dilation (focal involving the left hepatic lobe) (G2)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (G3)
CL Item
Extrahepatic ductal dilation (G4)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (G5)
CL Item
Primary sclerosing cholangitis (G7)
CL Item
Choledocholithiasis (gallstone in duct) (G8)
CL Item
Ductal filling defect(s), other than gallstone (G9)
CL Item
Ductal wall thickening or oedema (G10)
CL Item
Choledochal cyst (G11)
CL Item
Ductal mass (G12)
CL Item
Extrinsic mass compressing bile duct(s) (G13)
CL Item
Other, specify (G99)
Specify other biliary duct lesion
Item
Specify other biliary duct lesion
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
H. Portal/Hepatic vein abnormalities?
text
C0032718 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0019155 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
H. Portal/Hepatic vein abnormalities?
Code List
H. Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Portal vein enlargement (H1)
CL Item
Hepatic vein enlargement (H2)
CL Item
Nonocclusive portal vein thrombus (H3)
CL Item
Occlusive portal vein thrombosis - bland (H4)
CL Item
Hepatic vein thrombosis - bland (H5)
CL Item
Occlusive portal vein thrombosis - malignant (H6)
CL Item
Hepatic vein thrombosis - malignant (H7)
CL Item
Involvement of the main portal vein (H8)
CL Item
Involvement of the right portal vein (H9)
CL Item
Involvement of the left portal vein (H10)
CL Item
Budd-Chiari syndrome (H11)
CL Item
other, specify (H99)
Specify other portal/hepatic vein abnormalities.
Item
Specify other 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])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
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