ID

41602

Beschreibung

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Stichworte

Versionen (3)
  1. 21.11.20 21.11.20 -
  2. 21.11.20 21.11.20 -
  3. 29.11.20 29.11.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

21. November 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Englisch

Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Status
Beschreibung

Status

Datentyp

text

Alias
UMLS CUI [1]
C0449438
Doc#
Beschreibung

Doc#

Datentyp

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Beschreibung

Is Page Blank?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Liver Biopsy
Beschreibung

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Beschreibung

Date of liver biopsy

Datentyp

date

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

Approximate size of liver biopsy:

Datentyp

integer

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Liver Biopsy - Final Diagnosis
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0193388
Spcify other final diagnosis
Beschreibung

Spcify other final diagnosis

Datentyp

text

Alias
UMLS CUI [1]
C1546485
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Liver Architecture
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
Specify other liver architecture
Beschreibung

Specify other liver architecture

Datentyp

text

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

Check all that apply

Datentyp

integer

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

Specify other Description of Liver Cells or Hepatocytes

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Liver Cells or Hepatocyte Inclusions or Vacuoles
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0227525
UMLS CUI [2]
C0042219
UMLS CUI [3]
C1512693
Secify other liver cells or hepatocyte inclusions or vaculoles
Beschreibung

Secify other liver cells or hepatocyte inclusions or vaculoles

Datentyp

text

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

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
Specify other hepatocyte or liver cell nuclear abnormalites
Beschreibung

Specify other hepatocyte or liver cell nuclear abnormalites

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Liver or Lobular Infiltrates
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
Specify other liver or lobular infiltrates
Beschreibung

Specify other liver or lobular infiltrates

Datentyp

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Portal Tract Inflammation
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C3854488
Specify other portal tract inflammation
Beschreibung

Specify other portal tract inflammation

Datentyp

text

Alias
UMLS CUI [1]
C3854488
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Bile Ducts
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0005400
Specify other bile ducts
Beschreibung

Specify other bile ducts

Datentyp

text

Alias
UMLS CUI [1]
C0005400
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Portal Veins
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0032718
Specify other portal veins
Beschreibung

Specify other portal veins

Datentyp

text

Alias
UMLS CUI [1]
C0032718
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Liver Infections
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C1112211
Specify other liver infections
Beschreibung

Specify other liver infections

Datentyp

text

Alias
UMLS CUI [1]
C1112211
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Parasites or Ova
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0030498
UMLS CUI [2]
C0555117
Specify other parasites or Ova
Beschreibung

Specify other parasites or Ova

Datentyp

text

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

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C1524062
Specify other Histologic Staining or Additional Studies Obtained
Beschreibung

Specify other Histologic Staining or Additional Studies Obtained

Datentyp

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C1524062
UMLS CUI [3]
C0205394
UMLS CUI [4]
C2348235
Liver Events Assessment
Beschreibung

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 stopping criteria?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [2,1]
C2746065
UMLS CUI [2,2]
C0243161
Liver Events
Beschreibung

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Date of assessment
Beschreibung

Date of assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
AE/SAE Reference Number
Beschreibung

AE/SAE Reference Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0237753
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [2]
C0304229
UMLS CUI [3,1]
C2746065
UMLS CUI [3,2]
C0243161
Specify other liver chemistry result
Beschreibung

Specify other liver chemistry result

Datentyp

text

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0587081
UMLS CUI [2]
C0205394
Is the subject age 55 or older?
Beschreibung

Is the subject age 55 or older?

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
If female, is the subject pregnant?
Beschreibung

If Yes, ensure Pregnancy Notification Form has been completed.

Datentyp

integer

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)?
Beschreibung

Were any diagnostic imaging tests of the liver or hepatobiliary system performed?

Datentyp

boolean

Alias
UMLS CUI [1]
C0011923
UMLS CUI [2]
C1711359
UMLS CUI [3]
C0023884
UMLS CUI [4,1]
C1456803
UMLS CUI [4,2]
C0023884
UMLS CUI [5]
C0040405
UMLS CUI [6]
C0024485
UMLS CUI [7]
C0008310
UMLS CUI [8]
C0205394
Were diagnostic imaging test results normal?
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1274040
UMLS CUI [2]
C0011923
UMLS CUI [3]
C0205307
Were any liver biopsies performed?
Beschreibung

If Yes, complete Liver Biopsy form.

Datentyp

boolean

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

If Yes, record on the appropriate Concomitant Medication form.

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

An unscheduled PK blood sample must be obtained within three half-lives (21 days) of last dose.

Datentyp

boolean

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

If Yes, date and time sample taken:

Datentyp

datetime

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

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

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0946444
UMLS CUI [3,1]
C0201734
UMLS CUI [3,2]
C0178913
UMLS CUI [3,3]
C0332152
Record the average number of units of alcohol consumed per week
Beschreibung

See eCRF Completion guidelines for conversion guidelines.

Datentyp

integer

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Liver Disease Medical Conditions
Beschreibung

Liver Disease Medical Conditions

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

Specific Condition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Check only one response for each condition
Beschreibung

Check only one response for each condition

Datentyp

integer

Alias
UMLS CUI [1]
C1704632
Drug related Liver Disease Conditions
Beschreibung

Drug related Liver Disease Conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Specific Condition
Beschreibung

Specific Condition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Check only one response for each condition
Beschreibung

Check only one response for each condition

Datentyp

integer

Alias
UMLS CUI [1]
C1704632
Other Liver Disease Conditions
Beschreibung

Other Liver Disease Conditions

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

Specific Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Check only one response for each condition
Beschreibung

Check only one response for each condition

Datentyp

integer

Alias
UMLS CUI [1]
C1704632
Other Medical Conditions
Beschreibung

Other Medical Conditions

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

Specific Condition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Check only one response for each condition
Beschreibung

Check only one response for each condition

Datentyp

integer

Alias
UMLS CUI [1]
C1704632
Liver Imaging
Beschreibung

Liver Imaging

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

Date of hepatic or liver imaging test:

Datentyp

date

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

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
Specify other method
Beschreibung

Specify other method

Datentyp

text

Alias
UMLS CUI [1,1]
C0871511
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Are images technically adequate?
Beschreibung

(Check one):

Datentyp

float

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

Specify other image quality

Datentyp

text

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

Check one

Datentyp

integer

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

Specify other liver size

Datentyp

text

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

Check one

Datentyp

integer

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

Specify other liver texture

Datentyp

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Grade the diffuse and/or geographic fatty infiltrate of the liver
Beschreibung

Check one

Datentyp

text

Alias
UMLS CUI [1]
C0015695
UMLS CUI [2]
C0205219
UMLS CUI [3]
C1517526
Specify other fatty infiltrate of the liver
Beschreibung

Check one

Datentyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Ascites present
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1]
C0003962
Specify other ascites
Beschreibung

Specify other ascites

Datentyp

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348235
Are focal hepatic lesions characterisable?
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
Specify other hepatic lesions
Beschreibung

Specify other hepatic lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Gallstones or gallbladder lesions?
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
Specify other gallstone or gallbladder lesions
Beschreibung

Specify other gallstone or gallbladder lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Biliary ductal lesions
Beschreibung

Check all that apply

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
Specify other biliary ductal lesions
Beschreibung

Specify other biliary ductal lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348235
Portal/Hepatic vein abnormalities
Beschreibung

Check all that apply

Datentyp

integer

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

Specify other portal/hepatic vein abnormalities

Datentyp

text

Alias
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]
C0205394
UMLS CUI [3]
C2348235
Liver event follow-up chemistries
Beschreibung

Liver event follow-up chemistries

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-4
C1522577
UMLS CUI-6
C0008000
Date sample taken
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1]
C1302413
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
Beschreibung

Were liver chemistries (ALT, AST, ALP, bilirubin) performed?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
Beschreibung

Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5]
C1278039
UMLS CUI [6]
C3714811
UMLS CUI [7]
C1293130
UMLS CUI [8,1]
C0332156
UMLS CUI [8,2]
C1442488
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Ähnliche Modelle

Liver Biopsy; Liver Events Assessment; Liver Imaging; Liver Event Follow-Up Chemistries

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
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:
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
Liver Biopsy - Final Diagnosis
integer
C1546485 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Liver Biopsy - Final Diagnosis
Code List
Liver Biopsy - Final Diagnosis
CL Item
Normal (1)
CL Item
Acute Hepatitis (2)
CL Item
Chronic Hepatitis (3)
CL Item
Cholestatic Hepatitis (4)
CL Item
Drug-Induced Cholestasis (5)
CL Item
Acute Viral Hepatitis (6)
CL Item
Chronic Viral Hepatitis (7)
CL Item
Drug-Induced Hepatitis (8)
CL Item
Autoimmune Hepatitis (9)
CL Item
Briding Necrosis (10)
CL Item
Submassive Hepatic Necrosis (11)
CL Item
Massive Hepatic Necrosis (12)
CL Item
Steatosis - Microvesicular (13)
CL Item
Steatosis - Macrovesicular (14)
CL Item
Steatosis - Mixed (15)
CL Item
Non-Alcoholic Steatohepatitis (16)
CL Item
Alcoholic Hepatitis (17)
CL Item
Hepatic Granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary Biliary Cirrhosis (22)
CL Item
Primary Sclerosing Cholangitis (23)
CL Item
Autoimmune Overlap Syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha-1-Antitrypsin Deficiency (26)
CL Item
Wilson's Disease (27)
CL Item
Veno-Occlusive Disease (28)
CL Item
Budd-Chiary Syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
Spcify other final diagnosis
Item
Spcify other final diagnosis
text
C1546485 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver Architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Liver Architecture
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Bridging Fibrosis (2)
CL Item
Diffuse Fibrosis (3)
CL Item
Nodular Regenerative Hyperplasia (4)
CL Item
Congenital Hepatic Fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular Congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-Occlusive Disease (9)
CL Item
Canalicular Cholestatis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) Hepatocellular Necrosis (12)
CL Item
Interface Hepatitis (Periportal Hepatitis or Piecemeal Necrosis) (13)
CL Item
Ischaemic Necrosis (14)
CL Item
Centrolobular (Zone 3) Necrosis (15)
CL Item
Focal Coagulative Necrosis (16)
CL Item
Centrolobular (Zone 3) Coagulative Necrosis (17)
CL Item
Bridging Hepatocellular Necrosis (18)
CL Item
Massive Or Panlobular Hepatocellular Necrosis (19)
CL Item
Dysplasia (20)
CL Item
Neoplasia (21)
CL Item
Other (22)
Specify other liver architecture
Item
Specify other liver architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Description of Liver Cells or Hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Description of Liver Cells or Hepatocytes
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated Giant Hepatocytes (5)
CL Item
Other (6)
Specify other Description of Liver Cells or Hepatocytes
Item
Specify other Description of Liver Cells or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver Cells or Hepatocyte Inclusions or Vacuoles
integer
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
Liver Cells or Hepatocyte Inclusions or Vacuoles
Code List
Liver Cells or Hepatocyte Inclusions or Vacuoles
CL Item
No Inclusions (1)
CL Item
Macrovesicular Steatosis (2)
CL Item
Microvesicular Steatosis (3)
CL Item
Bile Accumulation (4)
CL Item
Diastase-Resistant, PAS-Positive Cytoplasmic Inclusions (5)
CL Item
Alpha-1-Antitrypsin-Inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory Bodies (8)
CL Item
"Ground Glass" Inclusions (9)
CL Item
Lipofuscin Pigment (10)
CL Item
Hemosiderin Granules (11)
CL Item
Orcein-Positive Cytoplasmin Granules (12)
CL Item
Protoporphyrin Crystals (Birefringent Under Polarised Light) (13)
CL Item
Uroporphyrin Crystals (Red Fluorescence Under Ultraviolet Light) (14)
CL Item
Other (15)
Secify other liver cells or hepatocyte inclusions or vaculoles
Item
Secify other liver cells or hepatocyte inclusions or vaculoles
text
C0227525 (UMLS CUI [1])
C0042219 (UMLS CUI [2])
C1512693 (UMLS CUI [3])
C0205394 (UMLS CUI [4])
C2348235 (UMLS CUI [5])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Hepatocyte or Liver Cell Nuclear Abnormalities
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular Mitoses (2)
CL Item
Binucleated or Multinucleated Hepatocytes (3)
CL Item
CMV Inclusion Bodies (4)
CL Item
HSV Inclusions (5)
CL Item
Varicella Inclusions (6)
CL Item
Other (7)
Specify other hepatocyte or liver cell nuclear abnormalites
Item
Specify other hepatocyte or liver cell nuclear abnormalites
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver or Lobular Infiltrates
integer
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
Liver or Lobular Infiltrates
Code List
Liver or Lobular Infiltrates
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma Cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and Proliferating Kupfer Cells (6)
CL Item
Granulomas (7)
CL Item
Other (8)
Specify other liver or lobular infiltrates
Item
Specify other liver or lobular infiltrates
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Portal Tract Inflammation
integer
C3854488 (UMLS CUI [1])
Portal Tract Inflammation
Code List
Portal Tract Inflammation
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid Aggregates and/or Follicles (3)
CL Item
Plasma Cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and Macrophages (6)
CL Item
Other (7)
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
Bile Ducts
integer
C0005400 (UMLS CUI [1])
Bile Ducts
Code List
Bile Ducts
CL Item
Normal (1)
CL Item
Proliferation of Bile Ducts (Bile Ductular Reaction) (2)
CL Item
Dilation, Degeneration or Disruption of Portal Bile Ducts (3)
CL Item
Paucity of Bile Ducts (4)
CL Item
Periductal Fibrosis (5)
CL Item
Other (6)
Specify other bile ducts
Item
Specify other bile ducts
text
C0005400 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Portal Veins
integer
C0032718 (UMLS CUI [1])
Portal Veins
Code List
Portal Veins
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, Sclerosis or Occlusion of Portal Vein (3)
CL Item
Neoplastic Invasion of Portal Vein (4)
CL Item
Granulomatous Compression of Portal Vein (5)
CL Item
Other (6)
Specify other portal veins
Item
Specify other portal veins
text
C0032718 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Liver Infections
integer
C1112211 (UMLS CUI [1])
Liver Infections
Code List
Liver Infections
CL Item
Normal (1)
CL Item
Leishmaniasis Donovani (2)
CL Item
Plasmodium Falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus Neoformans (5)
CL Item
Histoplasma Capsulatum (6)
CL Item
Mycobacterium Tuberculosis (7)
CL Item
Other Mycobacterial Species (8)
CL Item
Other (9)
Specify other liver infections
Item
Specify other liver infections
text
C1112211 (UMLS CUI [1])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item
Parasites or Ova
integer
C0030498 (UMLS CUI [1])
C0555117 (UMLS CUI [2])
Parasites or Ova
Code List
Parasites or Ova
CL Item
None (1)
CL Item
Schistosome and/or Ova (2)
CL Item
Ascaris and/or Ova (3)
CL Item
Toxocara and/or Ova (4)
CL Item
Echinococcus Cysts (5)
CL Item
Hepatic Capillariasis Worm and/or Ova (6)
CL Item
Other (7)
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
Histologic Staining or Additional Studies Obtained
integer
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Histologic Staining or Additional Studies Obtained
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and Eosin (1)
CL Item
Masson (2)
CL Item
Toluidine Blue or Giemsa (3)
CL Item
Prussian Blue (4)
CL Item
Periodic Acidic Schiff (PAS), wih or without Diastase (5)
CL Item
Oil Red O (6)
CL Item
Congo Red (7)
CL Item
Hall's Stain (8)
CL Item
Gridley's Stain (9)
CL Item
Rhodanine (Copper) (10)
CL Item
Rubeanic Acid (Copper) (11)
CL Item
Orcein, Aldehyde Fuchsin or Victoria Blue (12)
CL Item
Electron Microscopy (13)
CL Item
Hepatitis A Immunostains Positive (14)
CL Item
Hepatitis B Core Antigen or Hepatitis B Surface Antibody Immunostains Positive (15)
CL Item
Hepatitis D Immunostains (16)
CL Item
Other Immunostains (17)
CL Item
Other (18)
Specify other Histologic Staining or Additional Studies Obtained
Item
Specify other Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3])
C2348235 (UMLS CUI [4])
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 stopping criteria?
Item
Have liver chemistry results reached or exceeded protocol-defined stopping criteria?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C2746065 (UMLS CUI [2,1])
C0243161 (UMLS CUI [2,2])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Date of assessment
Item
Date of assessment
date
C2985720 (UMLS CUI [1])
AE/SAE Reference Number
Item
AE/SAE Reference Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (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
Other, specify (4)
Specify other liver chemistry result
Item
Specify other liver chemistry result
text
C0008000 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
integer
C0032961 (UMLS CUI [1])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed?
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 [4,1])
C0023884 (UMLS CUI [4,2])
C0040405 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0008310 (UMLS CUI [7])
C0205394 (UMLS CUI [8])
Were diagnostic imaging test results normal?
Item
Were diagnostic imaging test results normal?
boolean
C1274040 (UMLS CUI [1])
C0011923 (UMLS CUI [2])
C0205307 (UMLS CUI [3])
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
C0200345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (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 [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0201734 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Record the average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
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
Epsein 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 or Biliary Disease (13)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
Check only one response for each condition
Code List
Check only one response for each condition
CL Item
Current (1)
CL Item
Past (2)
CL Item
No medical condition (3)
Item Group
Drug related Liver Disease Conditions
C0023895 (UMLS CUI-1)
C0277579 (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 related Liver Disease (1)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
Check only one response for each condition
Code List
Check only one response for each condition
CL Item
Current  (1)
CL Item
Past  (2)
CL Item
No medical condition (3)
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
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
Check only one response for each condition
Code List
Check only one response for each condition
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 (1)
CL Item
Rheumatoid Artheritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Iflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Check only one response for each condition
integer
C1704632 (UMLS CUI [1])
Check only one response for each condition
Code List
Check only one response for each condition
CL Item
Current  (1)
CL Item
Past  (2)
CL Item
No medical condition (3)
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
What method was used for this imaging test?
integer
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/Computed Tomography (PET/CT) (7)
CL Item
Other, specify (8)
Specify other method
Item
Specify other method
text
C0871511 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Are images technically adequate?
Item
Are images technically adequate?
float
C0806487 (UMLS CUI [1])
Specify other image quality
Item
Specify other image quality
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Indicate the liver size
integer
C0426688 (UMLS CUI [1])
Indicate the liver size
Code List
Indicate the liver size
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other specify (5)
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
Indicate the liver texture
integer
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Indicate the liver texture
Code List
Indicate the liver texture
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Specify other liver texture
Item
Specify other liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1])
C0205219 (UMLS CUI [2])
C1517526 (UMLS CUI [3])
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 (1)
CL Item
25%) (Mild (<)
CL Item
Moderate (>25% to <75%) (3)
CL Item
75%) (Severe (>)
CL Item
Other, specify (5)
Specify other fatty infiltrate of the liver
Item
Specify other fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Ascites present
integer
C0003962 (UMLS CUI [1])
Ascites present
Code List
Ascites present
CL Item
Non present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (4)
Specify other ascites
Item
Specify other ascites
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Item
Are focal hepatic lesions characterisable?
integer
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Are focal hepatic lesions characterisable?
Code List
Are focal hepatic lesions characterisable?
CL Item
Not applicable - no hepatic lesions (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Haemangioma (4)
CL Item
Focal nodular hyperplasia (5)
CL Item
Other (6)
Specify other hepatic lesions
Item
Specify other hepatic lesions
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Gallstones or gallbladder lesions?
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Gallstones or gallbladder lesions?
Code List
Gallstones or gallbladder lesions?
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder Polyps (S) (3)
CL Item
Sludge (4)
CL Item
Gallbladder Wall Thickening/Oedema (5)
CL Item
Gallbladder Wall Gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder Wall Calcification (8)
CL Item
Gallbladder Mass (9)
CL Item
Other (10)
Specify other gallstone or gallbladder lesions
Item
Specify other gallstone or gallbladder lesions
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Biliary ductal lesions
integer
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions
Code List
Biliary ductal lesions
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ductal filling defect (s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct (s) (14)
CL Item
Other (15)
Specify other biliary ductal lesions
Item
Specify other biliary ductal lesions
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Item
Portal/Hepatic vein abnormalities
integer
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 (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis (4)
CL Item
Occlusive portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Oclcusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
Involvement of the left portal vein (11)
CL Item
Budd-Chiari Syndrome (12)
CL Item
Other (13)
Specify other portal/hepatic vein abnormalities
Item
Specify other portal/hepatic vein abnormalities
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [3])
Item Group
Liver event follow-up chemistries
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1522577 (UMLS CUI-4)
C0008000 (UMLS CUI-6)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
Item
Were liver chemistries (ALT, AST, ALP, bilirubin) performed?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
Item
Did liver chemistries (AST, ALT, ALP, bilirubin) resolve, stabilize, or return to within Baseline values?
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C3714811 (UMLS CUI [6])
C1293130 (UMLS CUI [7])
C0332156 (UMLS CUI [8,1])
C1442488 (UMLS CUI [8,2])
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