ID

39399

Beschrijving

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

Trefwoorden

D009462

D016430

Liver

G20

07-01-20 07-01-20 -
09-01-20 09-01-20 -

Houder van rechten

GlaxoSmithKline

Geüploaded op

7 januari 2020

DOI

Voor een aanvraag inloggen.

Licentie

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

model
Details

Liver Assessments

1 Formulieren

StudyEvent: ODM
1. Liver Assessments

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative

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])

Liver Events

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])

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

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])

If female, is subject pregnant?

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])

When did the liver event occur?

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])

Alcohol intake at onset of liver event

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])

Medical Conditions at onset of liver event

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)

Liver Disease Medical Conditions

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)

Status of disease

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)

Drug related liver disease conditions

Item Group

Drug related liver disease conditions

C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)

Drug related liver disease

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)

Other Liver disease conditions

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])

Please specify other liver disease conditions

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])

Other medical conditions

Item Group

Other medical conditions

C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)

Liver Disease Medical Conditions

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)

Status of disease

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)

Pharmacokinetics

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])

Liver Imaging

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])

What method was used for this imaging test?

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])

Are images technically adequate?

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])

Indicate the liver size

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])

Indicate the liver texture

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])

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

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])

Acites present

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])

Are Focal Hepatic Lesions Characterisable?

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])

Gallstones or gallbladder lesions?

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])

Biliary ductal lesions?

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])

Portal/Hepatic vein abnormalities?

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])

Liver biopsy

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])

Liver biopsy final diagnosis

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])

Liver architecture

Item Group

Liver architecture

C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)

Liver architecture

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])

Description of liver cells or hepatocytes

Item Group

Description of liver cells or hepatocytes

C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)

Description of liver cells or hepatocytes

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])

Liver cell or hepatocyte inclusions or vaculoles

Item Group

Liver cell or hepatocyte inclusions or vaculoles

C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C1512693 (UMLS CUI-3)

Liver cell or hepatocyte inclusions or vaculoles

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])

Hepatocyte or liver cell nuclear abnormalities

Item Group

Hepatocyte or liver cell nuclear abnormalities

C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)

Hepatocyte or liver cell nuclear abnormalities

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])

Liver or lobular infiltrates

Item Group

Liver or lobular infiltrates

C1400896 (UMLS CUI-1)

Liver or lobular infiltrates

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])

Portal tract inflammation

Item Group

Portal tract inflammation

C3854488 (UMLS CUI-1)

Portal tract inflammation

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])

Bile Ducts

Item Group

Bile Ducts

C0005400 (UMLS CUI-1)

Bile Ducts

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])

Portal Veins

Item Group

Portal Veins

C0032718 (UMLS CUI-1)

Portal Veins

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])

Liver infections

Item Group

Liver infections

C1112211 (UMLS CUI-1)

Liver infections

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])

Parasites or Ova

Item Group

Parasites or Ova

C0030498 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0555117 (UMLS CUI-3)

Parasites or Ova

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])

Histologic staining or additinoal studies obtained

Item Group

Histologic staining or additinoal studies obtained

C0487602 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C2603343 (UMLS CUI-3)
C1524062 (UMLS CUI-4)

Histologic staining or additinoal studies obtained

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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Liver Assessments

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