ID

40310

Beskrivning

Study ID: 110635 Clinical Study ID: 110635 Study Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who had an inadequate response to methotrexate therapy (FINAL ANALYSIS: follow-up period and cumulative safety data across the whole study) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00611455 Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ofatumumab, Placebo Study Indication: Arthritis, Rheumatoid

Nyckelord

Versioner (2)
  1. 2020-04-02 2020-04-02 -
  2. 2020-04-02 2020-04-02 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

2 april 2020

DOI

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Licens

Creative Commons BY-NC 4.0
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Efficacy of ofatumumab in adult patients with active rheumatoid arthritis with inadequate response to methotrexate NCT00611455

Engelsk

Liver Imaging; Liver Biopsy; Subject Continuation; Electronically Transferred Lab Data

1 Formulär  
Liver Imaging
Beskrivning

Liver Imaging

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

Date of hepatic or liver imaging test

Datatyp

date

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

What method was used for this imaging test?

Datatyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
If other method was used for this imaging test, specify
Beskrivning

If other method was used for this imaging test, specify

Datatyp

text

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

Are images technically adequate?

Datatyp

text

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

If other image quality, specify

Datatyp

text

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

Indicate the liver size

Datatyp

text

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

If other liver size, specify

Datatyp

text

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

Indicate the liver texture

Datatyp

text

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

If other liver texture, specify

Datatyp

text

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

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

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [2]
C0441800
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
Beskrivning

If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [2]
C0441800
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
Ascites present
Beskrivning

Ascites present

Datatyp

text

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

If other ascites, specify

Datatyp

text

Alias
UMLS CUI [1]
C0003962
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Are Focal Hepatic Lesions characterisable?
Beskrivning

Check all that apply

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If other focal hepatic lesions, specify
Beskrivning

If other focal hepatic lesions, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Gallstones or gallbladder lesions?
Beskrivning

Check all that apply

Datatyp

text

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

If other gallstones or gallbladder lesions, specify

Datatyp

text

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

Check all that apply

Datatyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If other biliary ductal lesions, specify
Beskrivning

If other biliary ductal lesions, specify

Datatyp

text

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

Check all that apply

Datatyp

text

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

If other portal/hepatic vein abnormalities, specify?

Datatyp

text

Alias
UMLS CUI [1]
C0019155
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0032718
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
Liver Biopsy
Beskrivning

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Beskrivning

Date of liver biopsy

Datatyp

date

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

Approximate size of liver biopsy

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Final Diagnosis
Beskrivning

Check all that apply

Datatyp

text

Alias
UMLS CUI [1]
C1546485
If other final diagnosis, specify
Beskrivning

If other final diagnosis, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver architecture
Beskrivning

Check all that apply

Datatyp

text

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

If other liver architecture, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Description of Liver Cells or Hepatocytes
Beskrivning

Check all that apply

Datatyp

text

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

If other description of liver cells or hepatocytes, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver Cell or Hepatocyte Inclusions or Vacuoles
Beskrivning

Check all that apply

Datatyp

text

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

If other liver cell or hepatocyte inclusions or vacuoles, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Hepatocyte or Liver Cell Nuclear Abnormalities
Beskrivning

Check all that apply

Datatyp

text

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

If other hepatocyte or liver cell nuclear abnormalities, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver or Lobular Infiltrates
Beskrivning

Check all that apply

Datatyp

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
If other liver or lobular infiltrates, specify
Beskrivning

If other liver or lobular infiltrates, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Portal Tract Inflammation
Beskrivning

Check all that apply

Datatyp

text

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

If other portal tract inflammation, specify

Datatyp

text

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

Check all that apply

Datatyp

text

Alias
UMLS CUI [1]
C0005400
If other bile duct structure, specify
Beskrivning

If other bile duct structure, specify

Datatyp

text

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

Check all that apply

Datatyp

text

Alias
UMLS CUI [1]
C0032718
If other portal vein structure, specify
Beskrivning

If other portal vein structure, specify

Datatyp

text

Alias
UMLS CUI [1]
C0032718
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver Infections
Beskrivning

Check all that apply

Datatyp

text

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

If other liver infections, specify

Datatyp

text

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

Check all that apply

Datatyp

text

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

If other parasites or ova, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0555117
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Histologic Staining or Additional Studies Obtained
Beskrivning

Histologic Staining or Additional Studies Obtained

Datatyp

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0193388
If other histologic staining or additional studies obtained, specify
Beskrivning

If other histologic staining or additional studies obtained, specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0193388
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Subject Continuation
Beskrivning

Subject Continuation

Alias
UMLS CUI-1
C0805733
Is the subject continuing in the study Follow-up Period?
Beskrivning

If Yes, complete the Phase Conclusion section and proceed with the Follow-up Period If No, complete the phase conclusion section and complete End of study (EOS)

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C1522577
Electronically Transferred Lab Data
Beskrivning

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Biochemistry Date sample taken
Beskrivning

Biochemistry Date sample taken

Datatyp

date

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C1302413
Biochemistry sample taken not done
Beskrivning

Biochemistry sample taken not done

Datatyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Chem Lab type code
Beskrivning

Chem Lab type code

Datatyp

text

Alias
UMLS CUI [1,1]
C0005774
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0805701
Tillbaka till toppen

Similar models

Liver Imaging; Liver Biopsy; Subject Continuation; Electronically Transferred Lab Data

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Liver Imaging
C2711860 (UMLS CUI-1)
Date of hepatic or liver imaging test
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
text
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 (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 (OT)
If other method was used for this imaging test, specify
Item
If other method was used for this imaging test, specify
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Are images technically adequate?
text
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, specify (OT)
If other image quality, specify
Item
If other image quality, specify
text
C0806487 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Indicate the liver size
text
C0426688 (UMLS CUI [1])
Indicate the liver size
Code List
Indicate the liver size
CL Item
Normal size (A1)
CL Item
Hypertrophy (or enlarged) (A2)
CL Item
Atrophy (or smaller than normal) (A3)
CL Item
Segmental hypertrophy (A4)
CL Item
Other, specify (OT)
If other liver size, specify
Item
If other liver size, specify
text
C0426688 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Indicate the liver texture
Code List
Indicate the liver texture
CL Item
Normal (B1)
CL Item
Heterogenous (B2)
CL Item
Suggestive of fibrosis (B3)
CL Item
Nodular or suggestive of cirrhosis (B4)
CL Item
Other, specify (OT)
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2])
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 infiltration (C1)
CL Item
Mild (<=25%) (C2)
CL Item
Moderate (>25% to <75%) (C3)
CL Item
Severe (>=75%) (C4)
CL Item
Other, specify (OT)
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
Item
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Item
Ascites present
text
C0003962 (UMLS CUI [1])
Ascites present
Code List
Ascites present
CL Item
None present (D1)
CL Item
Yes - small amount (D2)
CL Item
Yes - moderate or severe amount (D3)
CL Item
Other, specify (OT)
If other ascites, specify
Item
If other ascites, specify
text
C0003962 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Are Focal Hepatic Lesions characterisable?
text
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 hepatic lesions (E0)
CL Item
Solid (E1)
CL Item
Cystic (E2)
CL Item
Hemangioma (E3)
CL Item
Focal Nodular Hyperplasia (E4)
CL Item
Other, specify (E99)
If other focal hepatic lesions, specify
Item
If other focal hepatic lesions, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Gallstones or gallbladder lesions?
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Gallstones or gallbladder lesions?
Code List
Gallstones or gallbladder lesions?
CL Item
None (F0)
CL Item
Gallstones (F1)
CL Item
Gallbladder polyp(s) (F2)
CL Item
Sludge (F3)
CL Item
Gallbladder wall thickening/oedema (F4)
CL Item
Gallbladder wall gas (F5)
CL Item
Cholecystitis (F6)
CL Item
Gallbladder wall calcification (F7)
CL Item
Gallbladder mass (F8)
CL Item
Other, specify (F9)
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions?
Code List
Biliary ductal lesions?
CL Item
None (G0)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (G1)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (G2)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (G3)
CL Item
Extrahepatic ductal dilation (G4)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (G5)
CL Item
Acute Cholangitis (G6)
CL Item
Primary sclerosing cholangitis (G7)
CL Item
Choledocholithiasis (gallstone in duct) (G8)
CL Item
Ductal filling defect(s), other than gallstone (G9)
CL Item
Ductal wall thickening or oedema (G10)
CL Item
Choledochal cyst (G11)
CL Item
Ductal mass (G12)
CL Item
Extrinsic mass compressing bile duct(s) (G13)
CL Item
Other, specify (G99)
If other biliary ductal lesions, specify
Item
If other biliary ductal lesions, specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal/Hepatic vein abnormalities?
text
C0019155 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
Portal/Hepatic vein abnormalities?
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (H0)
CL Item
Portal vein enlargement (H1)
CL Item
Hepatic vein enlargement (H2)
CL Item
Nonocclusive portal vein thrombosis (H3)
CL Item
Occlusive portal vein thrombosis - bland (H4)
CL Item
Hepatic vein thrombosis - bland (H5)
CL Item
Occlusive portal vein thrombosis - malignant (H6)
CL Item
Hepatic vein thrombosis - malignant (H7)
CL Item
Involvement of the main portal vein (H8)
CL Item
Involvement of the right portal vein (H9)
CL Item
Involvement of the left portal vein (H10)
CL Item
Budd-Chiari syndrome (H11)
CL Item
Other, specify (H99)
If other portal/hepatic vein abnormalities, specify?
Item
If other portal/hepatic vein abnormalities, specify?
text
C0019155 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
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 liver biopsy
Item
Approximate size of liver biopsy
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
Final Diagnosis
text
C1546485 (UMLS CUI [1])
Final Diagnosis
Code List
Final Diagnosis
CL Item
Normal (A0)
CL Item
Acute hepatitis (A1)
CL Item
Chronic hepatitis (A2)
CL Item
Cholestatic hepatitis (A3)
CL Item
Drug-induced cholestasis (A4)
CL Item
Acute viral hepatitis (A5)
CL Item
Chronic viral hepatitis (A6)
CL Item
Drug-induced hepatitis (A7)
CL Item
Autoimmune hepatitis (A8)
CL Item
Bridging necrosis (A9)
CL Item
Submassive hepatic necrosis (A10)
CL Item
Massive hepatic necrosis (A11)
CL Item
Steatosis - microvesicular (A12)
CL Item
Steatosis - macrovesicular (A13)
CL Item
Steatosis - mixed (A14)
CL Item
Non-alcoholic steatohepatitis (A15)
CL Item
Alcoholic hepatitis (A16)
CL Item
Hepatic granulomas (A17)
CL Item
Sarcoidosis (A18)
CL Item
Fibrosis (A19)
CL Item
Cirrhosis (A20)
CL Item
Primary biliary cirrhosis (A21)
CL Item
Primary sclerosing cholangitis (A22)
CL Item
Autoimmune overlap syndrome (A23)
CL Item
Hemochromatosis (A24)
CL Item
Alpha-1-antitrypsin deficiency (A25)
CL Item
Wilson's disease (A26)
CL Item
Veno-occlusive disease (A27)
CL Item
Budd-Chiari syndrome (A28)
CL Item
Neoplasia (A29)
CL Item
Other, specify (A99)
If other final diagnosis, specify
Item
If other final diagnosis, specify
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Liver architecture
Code List
Liver architecture
CL Item
Normal (B1)
CL Item
Bridging fibrosis (B2)
CL Item
Diffuse fibrosis (B3)
CL Item
Nodular regenerative hyperplasia (B4)
CL Item
Congenital hepatic fibrosis (B5)
CL Item
Cirrhosis (B6)
CL Item
Centrilobular congestion (B7)
CL Item
Endophlebitis (B8)
CL Item
Veno-occlusive disease (B9)
CL Item
Canalicular cholestasis (B10)
CL Item
Apoptosis (B11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis (B12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis) (B13)
CL Item
Ischaemic necrosis (B14)
CL Item
Centrolobular (Zone 3) necrosis (B15)
CL Item
Focal coagulative necrosis (B16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (B17)
CL Item
Bridging hepatocellular necrosis (B18)
CL Item
Massive or panlobular hepatocellular necrosis (B19)
CL Item
Dysplasia (B20)
CL Item
Neoplasia (B21)
CL Item
Other, specify (B99)
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Description of Liver Cells or Hepatocytes
text
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 (C0)
CL Item
Ballooning (C1)
CL Item
Acidophilic (C2)
CL Item
Pseudoxanthomathous (C3)
CL Item
Multinucleated giant hepatocytes (C4)
CL Item
Other, specify (C99)
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])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Liver Cell or Hepatocyte Inclusions or Vacuoles
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
Normal (D0)
CL Item
Macrovesicular steatosis (D1)
CL Item
Microvesicular steatosis (D2)
CL Item
Bile accumulation (D3)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (D4)
CL Item
Alpha-1-antitrypsin inclusions (D5)
CL Item
Megamitochondria (D6)
CL Item
Mallory bodies (D7)
CL Item
"Ground Glass" inclusions (D8)
CL Item
Lipofuscin pigment (D9)
CL Item
Hemosiderin granules (D10)
CL Item
Orcein-positive cytoplasmin granules (D11)
CL Item
Orcein-positive cytoplasmin granules (D12)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (D13)
CL Item
Other, specify (D99)
If other liver cell or hepatocyte inclusions or vacuoles, specify
Item
If other liver cell or hepatocyte inclusions or vacuoles, specify
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
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 (E0)
CL Item
Hepatocellular mitosis (E1)
CL Item
Binucleated or multinucleated hepatocytes (E2)
CL Item
CMV inclusion bodies (E3)
CL Item
HSV inclusions (E4)
CL Item
Varicella inclusions (E5)
CL Item
Other, specify (E99)
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])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver or Lobular Infiltrates
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
Liver or Lobular Infiltrates
Code List
Liver or Lobular Infiltrates
CL Item
None (F0)
CL Item
Eosinophils (F1)
CL Item
Lymphocytes (F2)
CL Item
Plasma cells (F3)
CL Item
Neutrophils (F4)
CL Item
Macrophages and proliferating Kupffer cells (F5)
CL Item
Granulomas (F6)
CL Item
Other, specify (F99)
If other liver or lobular infiltrates, specify
Item
If other liver or lobular infiltrates, specify
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
Portal Tract Inflammation
Code List
Portal Tract Inflammation
CL Item
None (G0)
CL Item
Eosinophils (G1)
CL Item
Lymphoid aggregates and/or follicles (G2)
CL Item
Plasma cells (G3)
CL Item
Neutrophils (G4)
CL Item
Histocytes and macrophages (G5)
CL Item
Other, specify (G99)
If other portal tract inflammation, specify
Item
If other portal tract inflammation, specify
text
C3854488 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Bile Ducts
text
C0005400 (UMLS CUI [1])
Bile Ducts
Code List
Bile Ducts
CL Item
Normal (H0)
CL Item
Proliferation of bile ducts (bile ductular reaction) (H1)
CL Item
Dilation, degeneration or disruption of portal bile ducts (H2)
CL Item
Paucity of bile ducts (H3)
CL Item
Periductal fibrosis (H4)
CL Item
Other, specify (H99)
If other bile duct structure, specify
Item
If other bile duct structure, specify
text
C0005400 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal Veins
text
C0032718 (UMLS CUI [1])
Portal Veins
Code List
Portal Veins
CL Item
Nomal (I0)
CL Item
Pyelophlebitis (I1)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (I2)
CL Item
Neoplastic invasion of portal vein (I3)
CL Item
Granulomatous compression of portal vein (I4)
CL Item
Other, specify (I99)
If other portal vein structure, specify
Item
If other portal vein structure, specify
text
C0032718 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver Infections
text
C1112211 (UMLS CUI [1])
Liver Infections
Code List
Liver Infections
CL Item
Normal (J0)
CL Item
Leishmaniasis donovani (J1)
CL Item
Plasmodium falciparum (J2)
CL Item
Toxoplasmosis (J3)
CL Item
Cryptococcus neoformans (J4)
CL Item
Histoplasma capsulatum (J5)
CL Item
Mycobacterium tuberculois (J6)
CL Item
Other mycobacterial species (J7)
CL Item
Other, specify (J99)
If other liver infections, specify
Item
If other liver infections, specify
text
C1112211 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Parasites or Ova
text
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 (K0)
CL Item
Schistosome and/or ova (K1)
CL Item
Ascaris and/or ova (K2)
CL Item
Toxocara and/or ova (K3)
CL Item
Echinococcus cysts (K4)
CL Item
Hepatic capillariasis worms and/or ova (K5)
CL Item
Other, specify (K99)
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
Histologic Staining or Additional Studies Obtained
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E) (L1)
CL Item
Masson (L2)
CL Item
Toluidine blue or Giemsa (L3)
CL Item
Prussian blue (L4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (L5)
CL Item
Oil red O (L6)
CL Item
Congo red (L7)
CL Item
Hall's stain (L8)
CL Item
Gridley's stain (L9)
CL Item
Rhodanine (copper) (L10)
CL Item
Rubeanic acid (copper)  (L11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (L12)
CL Item
Electron microscopy (L13)
CL Item
Hepatitis A immunostains positive (L14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (L15)
CL Item
Hepatitis D immunostains (L16)
CL Item
Other immunostains (L17)
CL Item
Other, specify (L99)
If other histologic staining or additional studies obtained, specify
Item
If other histologic staining or additional studies obtained, specify
text
C0487602 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Is the subject continuing in the study Follow-up Period?
Item
Is the subject continuing in the study Follow-up Period?
boolean
C0805733 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
Item Group
Electronically Transferred Lab Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Biochemistry Date sample taken
Item
Biochemistry Date sample taken
date
C0005477 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
Biochemistry sample taken not done
text
C0005477 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Biochemistry sample taken not done
Code List
Biochemistry sample taken not done
CL Item
Not Done (ND)
Chem Lab type code
Item
Chem Lab type code
text
C0005774 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
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