Informações: Esta não é a versão mais recente do modelo de dados. Uma visão geral da versão pode ser encontrada à esquerda em Versões. Para a versão mais recente, clique aqui.
Informações:
Falhas:
ID
39399
Descrição
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
Palavras-chave
Versões (2)
- 07/01/2020 07/01/2020 -
- 09/01/2020 09/01/2020 -
Titular dos direitos
GlaxoSmithKline
Transferido a
7 de janeiro de 2020
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Ropinirole prolonged release (PR) as adjunctive treatment to L-Dopa in patients with advanced Parkinson's disease
Similar models
Liver Assessments
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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 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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
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])
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])
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)
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])
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)
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])
C0012634 (UMLS CUI [1,2])
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)
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)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
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)
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])
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])
C0012634 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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])
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)
C0205394 (UMLS CUI-2)
Item
Liver Disease Medical Conditions
integer
C0023895 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,2])
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)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C1275506 (UMLS CUI [1,2])
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])
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])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
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])
C0023884 (UMLS CUI [1,2])
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])
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])
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])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
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])
C0205234 (UMLS CUI [1,2])
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])
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])
C0221198 (UMLS CUI [1,2])
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])
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])
C0221198 (UMLS CUI [1,2])
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])
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])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
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])
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])
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C0456389 (UMLS CUI [1,2])
Item
Liver biopsy final diagnosis
integer
C0193388 (UMLS CUI [1,1])
C1546485 (UMLS CUI [1,2])
C1546485 (UMLS CUI [1,2])
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])
C1546485 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Liver architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
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])
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)
C0678257 (UMLS CUI-2)
Item
Description of liver cells or hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
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])
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)
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])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
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])
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)
C1849376 (UMLS CUI-2)
Item
Hepatocyte or liver cell nuclear abnormalities
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
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])
C1849376 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
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])
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)
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])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
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])
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)
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])
C0023884 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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])
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])