Informatie:
Fout:
ID
31630
Beschrijving
Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders
Trefwoorden
Versies (1)
- 14-09-18 14-09-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
14 september 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384
Liver Event DoV, Liver Events, Investigational product (liver), Pharmacokinetics (liver), Medical conditions (liver), Alcohol intake, Liver imaging repeating, Liver biopsy
Similar models
Liver Event DoV, Liver Events, Investigational product (liver), Pharmacokinetics (liver), Medical conditions (liver), Alcohol intake, Liver imaging repeating, Liver biopsy
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Liver Event (DoV)
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1320303 (UMLS CUI-3)
C0877248 (UMLS CUI-2)
C1320303 (UMLS CUI-3)
Date of visit | Assessment Date
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
C2985720 (UMLS CUI [2])
Chemistry, Clinical; Liver function | Experimental drug; reason for stopping medication
Item
Have liver chemistry results reached or exceeded protocol- defined investigational product stopping criteria?
boolean
C0008000 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
C0232741 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping criteria? Check all that apply.
integer
C0008000 (UMLS CUI [1,1])
C0232741 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C213363 (UMLS CUI [2,2])
C0232741 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C213363 (UMLS CUI [2,2])
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping criteria? Check all that apply.
CL Item
ALT (alanine aminotransferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5' nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
Age
Item
Is the subject 55 or older?
boolean
C0001779 (UMLS CUI [1])
CL Item
Yes (ensure Pregnancy Notification Form has been completed) (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Diagnostic Imaging; Hepatobiliary System; Liver | Ultrasonics (sound); Liver | X-Ray Computed Tomography | Magnetic Resonance Imaging | Endoscopic Retrograde Cholangiopancreatography | Other
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
C0205394 (UMLS CUI [6])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1456803 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0040405 (UMLS CUI [3])
C0024485 (UMLS CUI [4])
C0008310 (UMLS CUI [5])
C0205394 (UMLS CUI [6])
Diagnostic Imaging; Hepatobiliary System; Liver | Result
Item
If diagnostic imaging test of the liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [2])
Biopsy of liver (procedure)
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbal Drugs | Alternative Medicine | Dietary Supplements | Illicit medication use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C1360419 (UMLS CUI [1])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
Fasting | Change in diet
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2])
C3671772 (UMLS CUI [2])
Item Group
Investigational product (liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0023884 (UMLS CUI-2)
Experimental drug; Start Date
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Item
Start Date Investigational Drug not applicable
integer
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
CL Item
Not applicable (1)
Experimental drug; End Date
Item
End Date Investigational Drug
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Item
End Date Investigational Drug not applicable
integer
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
CL Item
Not applicable (1)
Item Group
Pharmacokinetics (liver)
C0031327 (UMLS CUI-1)
C0232741 (UMLS CUI-2)
C0232741 (UMLS CUI-2)
Collection of blood specimen for laboratory procedure; Pharmacokinetic aspects
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic aspects; Specimen collection date | Pharmacokinetic aspects; Specimen Collection; Time
Item
If pharmacokinetic blood sample was obtained, date and time sample taken
datetime
C0031328 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C1302413 (UMLS CUI [1,2])
C0031328 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Pharmacokinetic aspects; Experimental drug; Drug dose; Specimen collection date | Pharmacokinetic aspects; Experimental drug; Drug dose; Specimen Collection; Time Unit
Item
If pharmacokinetic blood sample was obtained, date and time of last investigational product dose prior to PK sample
datetime
C0031328 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
C0031328 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0200345 (UMLS CUI [2,4])
C0040223 (UMLS CUI [2,5])
C0304229 (UMLS CUI [1,2])
C0678766 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
C0031328 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0200345 (UMLS CUI [2,4])
C0040223 (UMLS CUI [2,5])
Sample identification number
Item
Sample Identifier/ Sample Number
text
C1299222 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
C0014644 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease or biliary disease
integer
C0016977 (UMLS CUI [1])
C3275124 (UMLS CUI [2])
C3275124 (UMLS CUI [2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
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)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
Liver diseases; Specification
Item
Specific Liver Disease Condition
text
C0023895 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
Status of other Liver Disease Condition
integer
C0023895 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
Item
Drug Allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption | alcohol units/week
Item
If subjects consumes alcohol, record the average number of units of alcohol consumed per week.
float
C0001948 (UMLS CUI [1])
C0560579 (UMLS CUI [2])
C0560579 (UMLS CUI [2])
Imaging of liver; Date in time
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])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
CL Item
Ultrasound- transabdominal (1)
CL Item
Ultrasound- endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computed Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/Computerised Tomograpy (PET/CT) (7)
CL Item
Other, specify (99)
Imaging of liver; Evaluation Method; Other; Specification
Item
If other method of imaging of liver, please specify.
text
C2711860 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C2911685 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other, specify (99)
undefined itemimage quality; Other; Specification
Item
If other image quality, please 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, specify (99)
Liver size (observable entity); Other; Specification
Item
If other liver size, please 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
text
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 cirrhosis (4)
CL Item
Other, specify (99)
Texture Perception; Liver; Other; Specification
Item
If other liver texture, please 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
C0015695 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
CL Item
Not applicable - no fatty infiltration (1)
CL Item
Mild (<= 25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>75%) (4)
CL Item
Other, specify (99)
Fatty Liver; Grade; Other; Specification
Item
If other grade of fatty infiltrate of the liver, please specify.
text
C0015695 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
CL Item
None present (1)
CL Item
Yes- small amount (2)
CL Item
Yes- moderate or severe amount (3)
CL Item
Other, specify (99)
Ascites; Finding; Other; Specification
Item
If other finding of ascites, please specify.
text
C0003962 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
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 hepatic lesions (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (99)
Lesion of liver; Focal; Other; Specification
Item
If other Focal Hepatic Lesions, please specify.
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Gallstones or gallbladder lesions?
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,2])
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyp(s) (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/ oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystis (7)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other, specify (99)
Gallstones/gallbladder problems; Lesion; Other; Specification
Item
If other gallbladder lesions, please 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 lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ductal filling defect(s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other (99)
Biliary tract structure; Lesion; Other; Specification
Item
If other biliary ductal lesion, please 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
Nonocclusive 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 pportal vein (10)
CL Item
Involvement of the left portal vein (11)
CL Item
Budd- Chiari syndrome (12)
CL Item
Other, specify (99)
Structure of hepatic vein; Abnormality; Other; Specification | Portal vein structure; Abnormality; Other; Specification
Item
If other Portal/ Hepatic vein abnormality, please 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])
Biopsy of liver (procedure); Date in time
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Biopsy of liver (procedure); Specimen size
Item
Approximate size of liver biopsy
float
C0193388 (UMLS CUI [1,1])
C1299482 (UMLS CUI [1,2])
C1299482 (UMLS CUI [1,2])
Specimen size; Unit of Measure; Biopsy of liver (procedure)
Item
Biopsy size unit
text
C1299482 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
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 steatohepatitis (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis (22)
CL Item
Primary sclerosing cholangitis (23)
CL Item
Autoimmune overlap syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha-1-antitrypsin deficiency (26)
CL Item
Wilson's disease (27)
CL Item
Veno- occlusive disease (28)
CL Item
Budd- Chiari syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other, specify (31)
Diagnosis Type - Final; Other; Specification
Item
If other final diagnosis, specify.
text
C1546485 (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
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(Zone3) 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, specify (22)
Liver; Cellular structure aspects; Other; Specification
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
Description of Liver Cells or Hepatocytes
integer
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C0007634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
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, specify (6)
Liver; Cells; Description; Other; Specification | Hepatocyte; Description; Other; Specification
Item
If other Description of Liver Cells or Hepatocytes, specify.
text
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0227525 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0007634 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0227525 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0023884 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C0227525 (UMLS CUI [3,1])
C0042219 (UMLS CUI [3,2])
C0227525 (UMLS CUI [4,1])
C1512693 (UMLS CUI [4,2])
C0007634 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0023884 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C0227525 (UMLS CUI [3,1])
C0042219 (UMLS CUI [3,2])
C0227525 (UMLS CUI [4,1])
C1512693 (UMLS CUI [4,2])
CL Item
No inclusions (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase- resistant, PAS- positive cytoplasmic inclusions (5)
CL Item
Alpha-1-antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein- positive cytoplasmin garnules (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (13)
CL Item
Uroporphyrin crystals (red fluorescense under ultraviolet light) (14)
CL Item
Other, specify (15)
Other Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
If other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify.
text
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0023884 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C0227525 (UMLS CUI [2,5])
C0042219 (UMLS CUI [2,6])
C0205394 (UMLS CUI [2,7])
C2348235 (UMLS CUI [2,8])
C0227525 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C2348235 (UMLS CUI [3,4])
C0007634 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0023884 (UMLS CUI [2,1])
C0007634 (UMLS CUI [2,2])
C1512693 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C0227525 (UMLS CUI [2,5])
C0042219 (UMLS CUI [2,6])
C0205394 (UMLS CUI [2,7])
C2348235 (UMLS CUI [2,8])
C0227525 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C0205394 (UMLS CUI [3,3])
C2348235 (UMLS CUI [3,4])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
integer
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C1849376 (UMLS CUI [2,2])
C0007634 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0227525 (UMLS CUI [2,1])
C1849376 (UMLS CUI [2,2])
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, specify (7)
Liver; Cells; Abnormal nuclear morphology; Other; Specification | Hepatocyte; Abnormal nuclear morphology; Other; Specification
Item
If other Hepatocyte or Liver Cell Nuclear Abnormalities, specify.
text
C0023884 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0227525 (UMLS CUI [2,1])
C1849376 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0007634 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C0227525 (UMLS CUI [2,1])
C1849376 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item
Liver or Lobular Infiltrates
integer
C1400896 (UMLS CUI [1])
C0205417 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0205417 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
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 Kuppfer cells (6)
CL Item
Granulomas (7)
CL Item
Other, specify (8)
liver; infiltrate; Other; Specification | Lobular; Infiltration; Other; Specification
Item
If other Liver or Lobular Infiltrates, specify.
text
C1400896 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205417 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205417 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/ or follicles (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other, specify (7)
Portal tract inflammation; Other; Specification
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
Dilatation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other, specify (6)
undefined item
Item
If other structure of bile duct, 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
Oher, specify (6)
Portal vein structure; Other; Specification
Item
If other structure of Porrtal Vein, 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 falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Mycobacterium tuberculosis (7)
CL Item
Other myobacterial species (8)
CL Item
Other, specify (9)
Hepatic infection; Other; Specification
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
Parasites or Ova
integer
C0030498 (UMLS CUI [1,1])
C0555117 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,2])
CL Item
Normal (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, specify (7)
Parasites; Ova in feces; Other; Specification
Item
If other Parasites or Ova, specify.
text
C0030498 (UMLS CUI [1,1])
C0555117 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0555117 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Histologic Staining or Additional Studies Obtained
integer
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0392366 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0023884 (UMLS CUI [1,2])
C0392366 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
CL Item
Haematoxylin and eosin (or H&E) (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
Gridley's stain (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Staining method; Liver; Other; Specification | Tests (qualifier value); Additional; Other; Specification
Item
If other Histologic Staining or Additional Studies Obtained, specify.
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392366 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0392366 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])