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Fehler:
ID
35640
Beschreibung
Study ID: 111611 Clinical Study ID: 111611 Study Title: A randomised, double-blind, placebo-controlled study to assess the effect of oral, single dose SB-705498 in a validated intranasal capsaicin challenge model in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00731250 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB-705498, Placebo, Caspaicin Trade Name: N/A Study Indication: Rhinitis
Stichworte
Versionen (1)
- 13.03.19 13.03.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
13. März 2019
DOI
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Creative Commons BY-NC 3.0
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The effect of intranasal capsaicin challenge model in healthy volunteers - 111611
Ähnliche Modelle
Liver Event Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Visit Date
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Liver Chemistry Results
Item
Have liver chemistry results reached or exceeded protocol-defined investigational product stopping criteria?
boolean
Liver Chemistry Results - Exceeding
Item
If liver chemistry results exceeded stopping criteria, stop investigational product, complete date stopped and Liver Event section
text
ALT (alanine aminotransferase)
Item
ALT (alanine aminotransferase)
boolean
C0151905 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
AST (aspartate aminotransferase)
Item
AST (aspartate aminotransferase)
boolean
C0201899 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Total bilirubin
Item
Total bilirubin
boolean
C0201913 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Alkaline phosphatase
Item
Alkaline phosphatase
boolean
C0201850 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
5' nucleotidase
Item
5' nucleotidase
boolean
C2700357 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Gammaglutamyltranspeptidase
Item
Gammaglutamyltranspeptidase
boolean
C0541979 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
age
Item
Is the subject age 55 or older?
boolean
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
diagnostic imaging tests
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed?
boolean
Results of diagnostic imaging
Item
Were the results normal?
boolean
biopsy
Item
Were any biopsies performed?
boolean
concomitant substances
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
Start Date Investigational Product
Item
Start Date of Investigational Product
date
End Date Investigational Product
Item
End Date of Investigational Product
date
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
pharmacokinetic blood sample datetime
Item
Date and Time of pharmacokinetic blood sample obtained
datetime
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 (5)
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)
disease sequence number
Item
disease sequence number
integer
Drug related liver diseases and conditions
Item
Specific condition
text
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)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
Item
Status of 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 Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0205394 (UMLS CUI-2)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Alcohol Intake
Item
Does the subject consume alcohol?
boolean
undefined item
Item
Record the average number of units of alcohol consumed per week
float
Date of hepatic or liver imaging tes
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 (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/ Computerised Tomography (PET/ CT) (7)
CL Item
Other, specify (8)
Other method used for imaging test
Item
If other method was used for imaging test, specify.
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, specify (4)
Other image quality
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, specify (5)
Other liver size
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
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Other liver texture
Item
If other liver texture, specify.
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Grade the diffuse and/ or geographic fatty infiltrate of the liver
integer
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
Code List
Grade the diffuse and/ or geographic fatty infiltrate of the liver
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 (5)
Other fatty infiltrate of the liver
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 amount (3)
CL Item
Other, specify (99)
Other ascites
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 (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (6)
Other focal hepatic lesions
Item
If other focal hepatic lesions, 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
Cholecystitis (7)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other, specify (10)
Other gallstones or gallbladder lesions
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 (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ductus) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ducta 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, specify (15)
Other biliary ductal lesions
Item
If other biliary ductal lesions, specify.
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (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
Occlusvie 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, specify (13)
Other portal/ hepatic vein abnormalities
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 liver biopsy
Item
Approximate size of liver biopsy
float
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
Item
Final Diagnosis Liver Biopsy
integer
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Final Diagnosis Liver Biopsy, if abnormal specify
integer
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
CL Item
Acute hepatitis (1)
CL Item
Chronic hepatitis (2)
CL Item
Cholestatic hepatitis (3)
CL Item
Drug-induced cholestasis (4)
CL Item
Acute viral hepatitis (5)
CL Item
Chronic viral hepatitis (6)
CL Item
Drug-induced hepatitis (7)
CL Item
Autoimmune hepatitis (8)
CL Item
Bridging necrosis (9)
CL Item
Submassive hepatic necrosis (10)
CL Item
Massive hepatic necrosis (11)
CL Item
Steatosis - microvesicular (12)
CL Item
Steatosis - macrovesicular (13)
CL Item
Steatosis - mixed (14)
CL Item
Non alcoholic steatohepatitis (15)
CL Item
Alcoholic hepatitis (16)
CL Item
Hepatic granutomas (17)
CL Item
Sarcoidosis (18)
CL Item
Fibrosis (19)
CL Item
Cirrhosis (20)
CL Item
Primacy biliary cirrhosis (21)
CL Item
Primary sclerosing cholangitis (22)
CL Item
Autoimmune overlap syndrome (23)
CL Item
Hemoch5omatosis (24)
CL Item
Alpha-1-antitcypsin deficiency (25)
CL Item
Wilson's disease (26)
CL Item
Veno-occlusive disease (27)
CL Item
Budd-Chiari syndrome (28)
CL Item
Neoplasia (29)
CL Item
Other, specify (30)
Final Diagnosis Liver Biopsy
Item
Final Diagnosis Liver Biopsy, if Other specify
text
C0011900 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,2])
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
Abnormal (2)
Item
Liver Architecture, if abnormal specify
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
C0935919 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
CL Item
Bridging fibrosis (1)
CL Item
Diffuse fibrosis (2)
CL Item
Nodular regenerative hyperplasia (3)
CL Item
Congenital hepatic fibrosis (4)
CL Item
Cirrhosis (5)
CL Item
Centrilobular congestion (6)
CL Item
Endophlebitis (7)
CL Item
Veno-occlusive disease (8)
CL Item
Canalicular cholestasis (9)
CL Item
Apoptosis (10)
CL Item
Focal (or spottyor mild ) hepatocellular necrosis (11)
CL Item
lnterface hepatitis (periportal hepatitis or piecemealnecrosis) (12)
CL Item
lschaemic necrosis (13)
CL Item
Centrolobular (Zone 3) necrosis (14)
CL Item
Foca l coagulative necrosis (15)
CL Item
Centrolobular (Zone 3) coagulative necrosis (16)
CL Item
Bridging hepatocellular necrosis (17)
CL Item
Massive or panlobular hepatoceltular necrosis (18)
CL Item
Dysplasia (19)
CL Item
Neoplasia (20)
CL Item
Other, specify (21)
Liver Architecture
Item
Liver Architecture, if Other specify
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0935919 (UMLS CUI [1,2])
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
Abnormal (2)
Item
Description of Liver Cells or Hepatocytes, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Code List
Description of Liver Cells or Hepatocytes, if abnormal, specify
CL Item
Ballooning (1)
CL Item
Acidophilic (2)
CL Item
Pseudoxanthomatous (3)
CL Item
Multinucleated giant hepatocytes (4)
CL Item
Other, specify (5)
Description of Liver Cells or Hepatocytes
Item
Description of Liver Cells or Hepatocytes, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles, if abnormal, specify
CL Item
Macrovesicular steatosis (1)
CL Item
Microvesicular steatosis (2)
CL Item
Bile accumulation (3)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (4)
CL Item
Alpha-1-antitrypsininclusions (5)
CL Item
Megamitochondria (6)
CL Item
Mallory bodies (7)
CL Item
"Ground Glass inclusions (8)
CL Item
Lipofuscinpigment (9)
CL Item
Hemosiderin granules (10)
CL Item
Orcein positive cytoplasmin granules (11)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (12)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (13)
CL Item
Other, specify (14)
Liver Cell or Hepatocyte Inclusions or Vacuoles
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [2])
C0042219 (UMLS CUI [1,2])
C1512693 (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])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Hepatocyte or Liver Cell Nuclear Abnormalities, if abnormal, specify
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities, if abnormal, specify
CL Item
Hepatocellular mitosis (1)
CL Item
Binucleated or multinucleated hepatocytes (2)
CL Item
CMV inclusion bodies (3)
CL Item
HSV inclusions (4)
CL Item
Varicella inclusions (5)
CL Item
Other, specify (6)
Hepatocyte or Liver Cell Nuclear Abnormalities
Item
Hepatocyte or Liver Cell Nuclear Abnormalities, if Other, specify
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,2])
Liver or Lobular Infiltrates
Item
Liver or Lobular Infiltrates
boolean
C1400896 (UMLS CUI [1])
Item
If Liver or Lobular Infiltrates, specify
integer
C1400896 (UMLS CUI [1])
CL Item
Eosinophils (1)
CL Item
Lymphocytes (2)
CL Item
Plasma cells (3)
CL Item
Neutrophils (4)
CL Item
Macrophages and proliferating Kupffer cells (5)
CL Item
Granulomas (6)
CL Item
Other, specify (7)
Liver or Lobular Infiltrates
Item
If Other Liver or Lobular Infiltrates, specify
text
C1400896 (UMLS CUI [1])
Portal Tract Inflammation
Item
Portal Tract Inflammation
boolean
C3854488 (UMLS CUI [1])
Item
If Portal Tract Inflammation, specify
integer
C3854488 (UMLS CUI [1])
CL Item
Eosinophils (1)
CL Item
Lymphoid aggregates and/or follicles (2)
CL Item
Plasma cells (3)
CL Item
Neutrophils (4)
CL Item
Histocytes and macrophages (5)
CL Item
Other, specify (6)
Portal Tract Inflammation
Item
If Other Portal Tract Inflammation, specify
text
C3854488 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Bile Ducts, if abnormal, specify
integer
C0005400 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
CL Item
Proliferation of bile ducts (bile ductular reaction) (1)
CL Item
Dilation, degeneration or disruption of portal bile ducts (2)
CL Item
Paucity of bile ducts (3)
CL Item
Periductal fibrosis (4)
CL Item
Other, specify (5)
Bile Ducts
Item
Bile Ducts, if Other, specify
text
C0005400 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
Item
Portal Veins, if abnormal, specify
integer
C0032718 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
CL Item
Pyelophlebitis (1)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (2)
CL Item
Neoplastic Invasion of portal vein (3)
CL Item
Granulomatous compression of portal vein (4)
CL Item
Other, specify (5)
Portal Veins
Item
Portal Veins, if other, specify
text
C0032718 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Leishmaniasis donovani (1)
CL Item
Plasmodium falciparum (2)
CL Item
Toxoplasmosis (3)
CL Item
Cryptococcus neoformans (4)
CL Item
Histoplasma capsulatum (5)
CL Item
Mycobacterium tuberculois (6)
CL Item
Other mycobacterial species (7)
CL Item
Other, specify (8)
Liver Infections
Item
If Other Liver Infections, specify
text
C1112211 (UMLS CUI [1])
Parasites or ova
Item
Parasites or ova
boolean
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Item
If Parasites or ova, specify
integer
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
CL Item
Schistosome and/or ova (1)
CL Item
Ascaris and/or ova (2)
CL Item
Toxocara and/or ova (3)
CL Item
Echinococcus cysts (4)
CL Item
Hepatic capillariasis worms and/or ova (5)
CL Item
Other, specify (6)
Parasites or ova
Item
If Other Parasites or ova, specify
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Item
Histologic Staining or Additional Studies Obtained
integer
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])
Code List
Histologic Staining or Additional Studies Obtained
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 (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
Orce in, aldehyde fuchsin or Victoria blue (12)
CL Item
Electronmicroscopy (13)
CL Item
Hepatitls A lmmunostains 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)
Histologic Staining or Additional Studies Obtained
Item
If Other Histologic Staining or Additional Studies Obtained, specify
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,2])