ID

39399

Descripción

Study ID: 111569 Clinical Study ID: 111569 Study Title: A fixed dose, dose-response study for ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01494532 Sponsor: GlaxoSmithKline Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Ropinirole, placebo

Palabras clave

Versiones (2)
  1. 7/1/20 7/1/20 -
  2. 9/1/20 9/1/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

7 de enero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease

Inglés

Liver Assessments

1 formularios  
  1. StudyEvent: ODM
    1. Liver Assessments
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Study Name
Descripción

Study Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2348560
Subject ID
Descripción

Subject ID

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Study Site
Descripción

Study Site

Tipo de datos

text

Alias
UMLS CUI [1]
C2825164
Liver Events
Descripción

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Liver Assessment Sequence Number
Descripción

Liver Assessment Sequence Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0220825
UMLS CUI [1,4]
C2348184
Is the liver event a serious adverse event?
Descripción

Please complete a SAE form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1519255
Was event changed to non-serious?
Descripción

Was event changed to non-serious?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0443172
Date event changed to non-serious
Descripción

Date event changed to non-serious

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0443172
UMLS CUI [1,4]
C0011008
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/follow up criteria?
Descripción

Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/follow up criteria?

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2746065
UMLS CUI [2,3]
C0243161
UMLS CUI [3,1]
C1522577
UMLS CUI [3,2]
C0243161
Is the subject age 55 or older?
Descripción

Is the subject age 55 or older?

Tipo de datos

boolean

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

Please complete a Pregnancy form.

Tipo de datos

integer

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

Were any diagnostic imaging tests of the liver or hepatobilary system performed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [3,1]
C0041618
UMLS CUI [3,2]
C0023884
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0008310
Were the results of imaging normal?
Descripción

Please ensure the overall diagnosis indicated by imaging is captured on the AE or SAE form.

Tipo de datos

boolean

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

Were any liver biopsies performed?

Tipo de datos

boolean

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

Please complete a Conmeds form.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C1148475
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0042890
UMLS CUI [5]
C0086190
Did the subject fast or undergo significantly dietary changes in the past week?
Descripción

Did the subject fast or undergo significantly dietary changes in the past week?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2,1]
C3671772
UMLS CUI [2,2]
C2826293
UMLS CUI [3]
C1444637
When did the liver event occur?
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
Start Date Investigational Product
Descripción

Start Date Investigational Product

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
End Date Investigational Product
Descripción

End Date Investigational Product

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Alcohol intake at onset of liver event
Descripción

Alcohol intake at onset of liver event

Alias
UMLS CUI-1
C0001948
UMLS CUI-3
C0023884
UMLS CUI-4
C0877248
Does the subject consume Alcohol?
Descripción

Does the subject consume Alcohol?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001948
Record the average number of units of alcohol consumed per week
Descripción

Record the average number of units of alcohol consumed per week

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Medical conditions at onset of liver event
Descripción

Medical conditions at onset of liver event

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
Liver Disease Medical Conditions
Descripción

Liver Disease Medical Conditions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0012634
Status of disease
Descripción

Status of disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0699749
Drug related liver disease conditions
Descripción

Drug related liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug related liver disease
Descripción

Drug related liver disease

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other Liver disease conditions
Descripción

Other Liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0012634
UMLS CUI-3
C0205394
Other Liver disease conditions - Sequence number
Descripción

Other Liver disease conditions - Sequence number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348184
Please specify other liver disease conditions
Descripción

Please specify other liver disease conditions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Please specify other liver disease conditions
Descripción

Please specify other liver disease conditions

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Other medical conditions
Descripción

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Liver Disease Medical Conditions
Descripción

Liver Disease Medical Conditions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0012634
Status of disease
Descripción

Status of disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0699749
Pharmacokinetics
Descripción

Pharmacokinetics

Alias
UMLS CUI-1
C0031328
Was a pharmacokinetic blood sample obtained?
Descripción

Was a pharmacokinetic blood sample obtained?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
Date and time of sample
Descripción

Date and time of sample

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Date and time of last investigational product dose prior to PK sample
Descripción

Date and time of last investigational product dose prior to PK sample

Tipo de datos

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]
C0031328
UMLS CUI [3,2]
C1277698
Liver Imaging
Descripción

Liver Imaging

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

Date of hepatic or liver imaging test

Tipo de datos

date

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

What method was used for this imaging test?

Tipo de datos

integer

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

Specify other method used for this imaging test

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Are images technically adequate?
Descripción

Are images technically adequate?

Tipo de datos

integer

Alias
UMLS CUI [1]
C0806487
If other image quality, specify.
Descripción

If other image quality, specify.

Tipo de datos

text

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

Indicate the liver size

Tipo de datos

integer

Alias
UMLS CUI [1]
C0426688
If other liver size, specify
Descripción

If other liver size, specify

Tipo de datos

text

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

Indicate the liver texture

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
If other liver texture, specify
Descripción

If other liver texture, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Grade the diffuse and/or geographic fatty infiltrate of the liver
Descripción

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

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0441800
UMLS CUI [1,2]
C0015695
UMLS CUI [1,3]
C0205219
UMLS CUI [2,1]
C0441800
UMLS CUI [2,2]
C0015695
UMLS CUI [2,3]
C1517526
If other fatty infiltrate of the liver, specify
Descripción

If other fatty infiltrate of the liver, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Acites present
Descripción

Acites present

Tipo de datos

integer

Alias
UMLS CUI [1]
C0003962
If other ascites, specify
Descripción

If other ascites, specify

Tipo de datos

text

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

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If other focal hepatic lesion, specify
Descripción

If other focal hepatic lesion, specify

Tipo de datos

text

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

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If other gallstones or gallbladder lesions, specify
Descripción

If other gallstones or gallbladder lesions, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Biliary ductal lesions?
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If other ductual lesion, specify
Descripción

If other ductual lesion, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Portal/Hepatic vein abnormalities?
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
If other portal/hepatic vein abnormalities, specify
Descripción

If other portal/hepatic vein abnormalities, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235
Liver biopsy
Descripción

Liver biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Descripción

Date of liver biopsy

Tipo de datos

date

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

Approximate size of the liver biopsy

Tipo de datos

integer

Unidades de medida
  • mm
Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0456389
mm
Liver biopsy final diagnosis
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1546485
If other final diagnosis, specify
Descripción

If other final diagnosis, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1546485
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Liver architecture
Descripción

Liver architecture

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0935919
Liver architecture
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
If other liver architecture, specify
Descripción

If other liver architecture, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Description of liver cells or hepatocytes
Descripción

Description of liver cells or hepatocytes

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C0678257
Description of liver cells or hepatocytes
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
If other description of liver cells or hepatocytes, specify
Descripción

If other description of liver cells or hepatocytes, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0205394
Liver cell or hepatocyte inclusions or vaculoles
Descripción

Liver cell or hepatocyte inclusions or vaculoles

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C0042219
UMLS CUI-3
C1512693
Liver cell or hepatocyte inclusions or vaculoles
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
If other liver cell or hepatocyte inclusions or vaculoles, specify
Descripción

If other liver cell or hepatocyte inclusions or vaculoles, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Hepatocyte or liver cell nuclear abnormalities
Descripción

Hepatocyte or liver cell nuclear abnormalities

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C1849376
Hepatocyte or liver cell nuclear abnormalities
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
If other hepatocyte or liver cell nuclear abnormalities, specify
Descripción

If other hepatocyte or liver cell nuclear abnormalities, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0205394
Liver or lobular infiltrates
Descripción

Liver or lobular infiltrates

Alias
UMLS CUI-1
C1400896
Liver or lobular infiltrates
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C1400896
If other liver or lobular infiltrates, specify
Descripción

If other liver or lobular infiltrates, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1400896
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Portal tract inflammation
Descripción

Portal tract inflammation

Alias
UMLS CUI-1
C3854488
Portal tract inflammation
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C3854488
If other portal tract inflammation, specify
Descripción

If other portal tract inflammation, specify

Tipo de datos

text

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

Bile Ducts

Alias
UMLS CUI-1
C0005400
Bile Ducts
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C0005400
If other bile ducts, specify
Descripción

If other bile ducts, specify

Tipo de datos

text

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

Portal Veins

Alias
UMLS CUI-1
C0032718
Portal Veins
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032718
If other portal veins, specify
Descripción

If other portal veins, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver infections
Descripción

Liver infections

Alias
UMLS CUI-1
C1112211
Liver infections
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1]
C1112211
If other liver infections, specify
Descripción

If other liver infections, specify

Tipo de datos

text

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

Parasites or Ova

Alias
UMLS CUI-1
C0030498
UMLS CUI-2
C0023884
UMLS CUI-3
C0555117
Parasites or Ova
Descripción

Check all that apply

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0555117
If other parasites or ova, specify
Descripción

If other parasites or ova, specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0555117
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Histologic staining or additinoal studies obtained
Descripción

Histologic staining or additinoal studies obtained

Alias
UMLS CUI-1
C0487602
UMLS CUI-2
C0023884
UMLS CUI-3
C2603343
UMLS CUI-4
C1524062
Histologic staining or additinoal studies obtained
Descripción

Histologic staining or additinoal studies obtained

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C1524062
If other histologic staining or additinoal studies obtained, specifiy
Descripción

If other histologic staining or additinoal studies obtained, specifiy

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C1524062
UMLS CUI [1,5]
C0205394
UMLS CUI [1,6]
C2348235
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Similar models

Liver Assessments

1 formularios
  1. StudyEvent: ODM
    1. Liver Assessments
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study Name
Item
Study Name
text
C2348560 (UMLS CUI [1])
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Study Site
Item
Study Site
text
C2825164 (UMLS CUI [1])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver Assessment Sequence Number
Item
Liver Assessment Sequence Number
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Is the liver event a serious adverse event?
Item
Is the liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Was event changed to non-serious?
Item
Was event changed to non-serious?
boolean
C0023884 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
Date event changed to non-serious
Item
Date event changed to non-serious
date
C0023884 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/follow up criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C1522577 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/follow up criteria?
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/follow up criteria?
CL Item
ALT (1)
CL Item
Total Bilirubin (2)
CL Item
Direct Bilirubin (3)
CL Item
INR (4)
CL Item
AST (5)
CL Item
Gammaglutamyltransferase (6)
CL Item
Other (7)
Is the subject age 55 or older?
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is subject pregnant?
integer
C0032961 (UMLS CUI [1])
If female, is subject pregnant?
Code List
If female, is subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Were any diagnostic imaging tests of the liver or hepatobilary system performed
Item
Were any diagnostic imaging tests of the liver or hepatobilary system performed (such as liver ultrasound, computerized tomography or CAT scan, magnetic resonance imaging, or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0041618 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Were the results of imaging normal?
Item
Were the results of imaging 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
C1360419 (UMLS CUI [1])
C1148475 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0042890 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
Did the subject fast or undergo significantly dietary changes in the past week?
Item
Did the subject fast or undergo significantly dietary changes in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C1444637 (UMLS CUI [3])
Item
When did the liver event occur?
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
When did the liver event occur?
Code List
When did the liver event occur?
CL Item
During the treatment period (1)
CL Item
After the treatment period (2)
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Alcohol intake at onset of liver event
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Does the subject consume Alcohol?
Item
Does the subject consume Alcohol?
boolean
C0001948 (UMLS CUI [1])
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
Medical conditions at onset of liver event
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
Item
Liver Disease Medical Conditions
integer
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Liver Disease Medical Conditions
Code List
Liver Disease Medical Conditions
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
Status of disease
integer
C0699749 (UMLS CUI [1])
Status of disease
Code List
Status of disease
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
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug related liver disease
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other Liver disease conditions
C0023895 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
C0205394 (UMLS CUI-3)
Other Liver disease conditions - Sequence number
Item
Other Liver disease conditions - Sequence number
integer
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Item
Please specify other liver disease conditions
integer
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Please specify other liver disease conditions
Code List
Please specify other liver disease conditions
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Please specify other liver disease conditions
Item
Please specify other liver disease conditions
text
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Liver Disease Medical Conditions
integer
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Liver Disease Medical Conditions
Code List
Liver Disease Medical Conditions
CL Item
Drug allergies (1)
CL Item
heumatoid Arthritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogrens Syndrome (7)
CL Item
Vertigo (8)
Item
Status of disease
integer
C0699749 (UMLS CUI [1])
Status of disease
Code List
Status of disease
CL Item
Current  (1)
CL Item
Past  (2)
CL Item
No Medical Condition (3)
Item Group
Pharmacokinetics
C0031328 (UMLS CUI-1)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date and time of sample
Item
Date and time of sample
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Date and time of last investigational product dose prior to PK sample
Item
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])
C0031328 (UMLS CUI [3,1])
C1277698 (UMLS CUI [3,2])
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 (M (3)
CL Item
Computerized Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholang (5)
CL Item
Positron Emission Tomography  (6)
CL Item
Positron Emission Tomography/ (7)
CL Item
Other (8)
Specify other method used for this imaging test
Item
Specify other method used for this imaging test
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Are images technically adequate?
integer
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 (4)
If other image quality, specify.
Item
If other image quality, specify.
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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 (5)
If other liver size, specify
Item
If other liver size, specify
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture
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
Heterogenous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhos (4)
CL Item
Other (5)
If other liver texture, specify
Item
If other liver texture, specify
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
integer
C0441800 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
C0205219 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2,1])
C0015695 (UMLS CUI [2,2])
C1517526 (UMLS CUI [2,3])
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 infiltratio (1)
CL Item
Mild (<=25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other (5)
If other fatty infiltrate of the liver, specify
Item
If other fatty infiltrate of the liver, specify
text
C0015695 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Acites present
integer
C0003962 (UMLS CUI [1])
Acites present
Code List
Acites present
CL Item
Non present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amoun (3)
CL Item
Other (4)
If other ascites, specify
Item
If other ascites, specify
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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 hepatiy lesions (1)
CL Item
Solid  (2)
CL Item
Cystic (3)
CL Item
Hemangioma  (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other (6)
If other focal hepatic lesion, specify
Item
If other focal hepatic lesion, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
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
Gallstones  (1)
CL Item
Gallbladder polyp(s) (2)
CL Item
Sludge  (3)
CL Item
Gallbladder wall thickening/oedema (4)
CL Item
Gallbladder wall gas  (5)
CL Item
Cholecystitis (6)
CL Item
Gallbladder wall calcification  (7)
CL Item
Gallbladder mass (8)
CL Item
Other (9)
If other gallstones or gallbladder lesions, specify
Item
If other gallstones or gallbladder lesions, specify
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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 (focal involving both right and left hepatic (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)
If other ductual lesion, specify
Item
If other ductual lesion, specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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
Non-occlusive portal vein thrombosis (4)
CL Item
Occlusive portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive 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)
If other portal/hepatic vein abnormalities, specify
Item
If other portal/hepatic vein abnormalities, specify
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
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 the liver biopsy
Item
Approximate size of the liver biopsy
integer
C0193388 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Liver biopsy final diagnosis
integer
C0193388 (UMLS CUI [1,1])
C1546485 (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
Bridging 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 steathepatitis (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-antitryspin deficiency (26)
CL Item
Wilson's disease (27)
CL Item
Veno-occlusive disease (28)
CL Item
Budd-Chiari syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
If other final diagnosis, specify
Item
If other final diagnosis, specify
text
C0193388 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Liver architecture
C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)
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 cholestasis (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)
If other liver architecture, specify
Item
If other liver architecture, specify
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Description of liver cells or hepatocytes
C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
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)
If other description of liver cells or hepatocytes, specify
Item
If other description of liver cells or hepatocytes, specify
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Liver cell or hepatocyte inclusions or vaculoles
C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)
Item
Liver cell or hepatocyte inclusions or vaculoles
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Liver cell or hepatocyte inclusions or vaculoles
Code List
Liver cell or hepatocyte inclusions or vaculoles
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-antirypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inslusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein-positive cytoplasmin granules (12)
CL Item
Protoporphyrin crystals (birefringent under polarized light) (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other (15)
If other liver cell or hepatocyte inclusions or vaculoles, specify
Item
If other liver cell or hepatocyte inclusions or vaculoles, specify
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Hepatocyte or liver cell nuclear abnormalities
C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)
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 mitosis (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)
If other hepatocyte or liver cell nuclear abnormalities, specify
Item
If other hepatocyte or liver cell nuclear abnormalities, specify
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item Group
Liver or lobular infiltrates
C1400896 (UMLS CUI-1)
Item
Liver or lobular infiltrates
integer
C1400896 (UMLS CUI [1])
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 Kupffer cells (6)
CL Item
Granulomas (7)
CL Item
Other (8)
If other liver or lobular infiltrates, specify
Item
If other liver or lobular infiltrates, specify
text
C1400896 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Portal tract inflammation
C3854488 (UMLS CUI-1)
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
Plasma cells (4)
CL Item
Histocytes and macrophages (6)
CL Item
Lymphoid aggregates and/or follicles (3)
CL Item
Neutrophils (5)
CL Item
Other (7)
If other portal tract inflammation, specify
Item
If other portal tract inflammation, specify
text
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Bile Ducts
C0005400 (UMLS CUI-1)
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
Paucity of bile ducts (4)
CL Item
Other (6)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Periductal fibrosis (5)
If other bile ducts, specify
Item
If other bile ducts, specify
text
C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Portal Veins
C0032718 (UMLS CUI-1)
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)
If other portal veins, specify
Item
If other portal veins, specify
text
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Liver infections
C1112211 (UMLS CUI-1)
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 falciparnum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Mycobacterium tuberculois (7)
CL Item
Other mycobacterial species (8)
CL Item
Other (9)
If other liver infections, specify
Item
If other liver infections, specify
text
C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Parasites or Ova
C0030498 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)
Item
Parasites or Ova
integer
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
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 worms and/or ova (6)
CL Item
Other (7)
If other parasites or ova, specify
Item
If other parasites or ova, specify
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Histologic staining or additinoal studies obtained
C0487602 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C2603343 (UMLS CUI-3)
C1524062 (UMLS CUI-4)
Item
Histologic staining or additinoal studies obtained
integer
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Histologic staining or additinoal studies obtained
Code List
Histologic staining or additinoal 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) with or without diastase (5)
CL Item
Oil red O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Grindley'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)
If other histologic staining or additinoal studies obtained, specifiy
Item
If other histologic staining or additinoal studies obtained, specifiy
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C1524062 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C2348235 (UMLS CUI [1,6])
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