ID

44033

Description

Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form is to be filled in if a liver biopsy is performed because of an Adverse Liver Event. There are seperate forms for general information on the liver event and for liver imaging (if performed).

Keywords

Versions (3)
  1. 10/26/19 10/26/19 -
  2. 11/12/19 11/12/19 - Sarah Riepenhausen
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

English

Liver Biopsy

1 forms  
  1. StudyEvent: ODM
    1. Liver Biopsy
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Liver biopsy number
Description

Liver biopsy number

Data type

integer

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0600091
Date of liver biopsy
Description

Date of liver biopsy

Alias
UMLS CUI-1
C0193388
UMLS CUI-2
C0011008
Date of liver biopsy
Description

Date of liver biopsy

Data type

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Biopsy size
Description

Biopsy size

Alias
UMLS CUI-1
C1299482
UMLS CUI-2
C0193388
Biopsy size
Description

Liver biopsy size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Biopsy size unit [hidden]
Description

[hidden] prefilled with "MM"

Data type

text

Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0193388
Final Diagnosis
Description

Final Diagnosis

Alias
UMLS CUI-1
C1546485
UMLS CUI-2
C0193388
Final Diagnosis
Description

Final Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0193388
Acute hepatitis
Description

Acute hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0267797
Chronic hepatitis
Description

Chronic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019189
Cholestatic hepatitis
Description

Cholestatic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0149904
Drug-induced cholestasis
Description

Drug-induced cholestasis

Data type

boolean

Alias
UMLS CUI [1]
C2062350
Acute viral hepatitis
Description

Acute viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0276622
Chronic viral hepatitis
Description

Chronic viral hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0276623
Drug-induced hepatitis
Description

Drug-induced hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C1262760
Autoimmune hepatitis
Description

Autoimmune hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0241910
Bridging necrosis
Description

Liver Bridging necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0333511
UMLS CUI [1,2]
C0023884
Submassive hepatic necrosis
Description

Submassive hepatic necrosis

Data type

boolean

Alias
UMLS CUI [1]
C0151798
Massive hepatic necrosis
Description

Massive hepatic necrosis

Data type

boolean

Alias
UMLS CUI [1]
C0001364
Steatosis - microvesicular
Description

Steatosis - microvesicular

Data type

boolean

Alias
UMLS CUI [1]
C1850415
Steatosis - macrovesicular
Description

Steatosis - macrovesicular

Data type

boolean

Alias
UMLS CUI [1]
C1837256
Steatosis - mixed
Description

Steatosis - mixed

Data type

boolean

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205430
Non-alcoholic steatohepatitis
Description

Non-alcoholic steatohepatitis

Data type

boolean

Alias
UMLS CUI [1]
C3241937
Alcoholic hepatitis
Description

Alcoholic hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C0019187
Hepatic granulomas
Description

Hepatic granulomas

Data type

boolean

Alias
UMLS CUI [1]
C0745754
Sarcoidosis
Description

Liver Sarcoidosis

Data type

boolean

Alias
UMLS CUI [1]
C0744822
Fibrosis
Description

Liver Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0239946
Cirrhosis
Description

Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
Primary biliary cirrhosis
Description

Primary biliary cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0008312
Primary sclerosing cholangitis
Description

Primary sclerosing cholangitis

Data type

boolean

Alias
UMLS CUI [1]
C0566602
Autoimmune overlap syndrome
Description

Autoimmune overlap syndrome

Data type

boolean

Alias
UMLS CUI [1]
C2702837
Hemochromatosis
Description

Hemochromatosis

Data type

boolean

Alias
UMLS CUI [1]
C0018995
Alpha-1-antitrypsin deficiency
Description

Alpha-1-antitrypsin deficiency

Data type

boolean

Alias
UMLS CUI [1]
C0221757
Wilson's disease
Description

Wilson's disease

Data type

boolean

Alias
UMLS CUI [1]
C0019202
Veno-occlusive disease
Description

Liver: Veno-occlusive disease

Data type

boolean

Alias
UMLS CUI [1]
C0019156
Budd-Chiari syndrome
Description

Budd-Chiari syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0856761
Neoplasia
Description

Liver Neoplasia

Data type

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0023884
Other Final Diagnosis, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
Other Final Diagnosis, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver Architecture
Description

Liver Architecture

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0935919
Liver Architecture
Description

If not normal, check all that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
Bridging fibrosis
Description

Bridging fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0334160
Diffuse fibrosis
Description

Diffuse fibrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0016059
UMLS CUI [1,2]
C0205219
Nodular regenerative hyperplasia
Description

Nodular regenerative hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C4048264
Congenital hepatic fibrosis
Description

Congenital hepatic fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0009714
Cirrhosis
Description

Cirrhosis

Data type

boolean

Alias
UMLS CUI [1]
C0023890
Centrilobular congestion
Description

Centrilobular congestion

Data type

boolean

Alias
UMLS CUI [1]
C0519014
Endophlebitis
Description

Endophlebitis

Data type

boolean

Alias
UMLS CUI [1]
C0014234
Veno-occlusive disease
Description

Veno-occlusive disease

Data type

boolean

Alias
UMLS CUI [1]
C0948441
Canalicular cholestasis
Description

Canalicular cholestasis

Data type

boolean

Alias
UMLS CUI [1]
C3150342
Apoptosis
Description

Apoptosis

Data type

boolean

Alias
UMLS CUI [1]
C0162638
Focal (or spotty or mild ) hepatocellular necrosis
Description

Focal hepatocellular necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1855038
UMLS CUI [1,2]
C0205234
lnterface hepatitis (periportal hepatitis or piecemeal necrosis)
Description

lnterface hepatitis

Data type

boolean

Alias
UMLS CUI [1]
C5139205
lschaemic necrosis
Description

lschaemic necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027540
UMLS CUI [1,2]
C0475224
Centrolobular (Zone 3) necrosis
Description

Centrolobular necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0027540
UMLS CUI [1,2]
C0682619
Focal coagulative necrosis
Description

Focal coagulative necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522058
UMLS CUI [1,2]
C0205234
Centrolobular (Zone 3) coagulative necrosis
Description

Centrolobular coagulative necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1522058
UMLS CUI [1,2]
C0682619
Bridging hepatocellular necrosis
Description

Bridging hepatocellular necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1855038
UMLS CUI [1,2]
C0333511
Massive or panlobular hepatocellular necrosis
Description

Massive or panlobular hepatocellular necrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1855038
UMLS CUI [1,2]
C0522501
UMLS CUI [2,1]
C1855038
UMLS CUI [2,2]
C0442131
Dysplasia
Description

Dysplasia liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0334044
UMLS CUI [1,2]
C0023884
Neoplasia
Description

Neoplasia liver

Data type

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0023884
Other Liver Architecture, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205394
Other Liver Architecture, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Description of Liver Cells or Hepatocytes
Description

Description of Liver Cells or Hepatocytes

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C0678257
Description of Liver Cells or Hepatocytes
Description

If not normal, check all that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
Ballooning
Description

Ballooning Hepatocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C0333445
UMLS CUI [1,2]
C0227525
Acidophilic
Description

Acidophilic Hepatocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0333931
Pseudoxanthomatous
Description

Pseudoxanthomatous Hepatocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C2348205
UMLS CUI [1,3]
C1710694
Multinucleated giant hepatocytes
Description

Multinucleated giant hepatocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C1850414
UMLS CUI [1,2]
C0227525
Other Description of Liver Cells or Hepatocytes, specify
Description

Please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0205394
Other Description of Liver Cells or Hepatocytes, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0678257
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Liver Cell or Hepatocyte Inclusions or Vacuoles

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C0042219
UMLS CUI-3
C0007637
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

If yes, check all inclusions/vacuoles that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [2,1]
C0227525
UMLS CUI [2,2]
C0007637
Macrovesicular steatosis
Description

Macrovesicular steatosis

Data type

boolean

Alias
UMLS CUI [1]
C1837256
Microvesicular steatosis
Description

Microvesicular steatosis

Data type

boolean

Alias
UMLS CUI [1]
C1850415
Bile accumulation
Description

Bile accumulation

Data type

boolean

Alias
UMLS CUI [1]
C3686784
Diastase-resistant, PAS-positive cytoplasmic inclusions
Description

Diastase-resistant, PAS-positive cytoplasmic inclusions

Data type

boolean

Alias
UMLS CUI [1]
C1856311
Alpha-1-antitrypsin inclusions
Description

Alpha-1-antitrypsin inclusions

Data type

boolean

Alias
UMLS CUI [1,1]
C0002191
UMLS CUI [1,2]
C0007637
Megamitochondria
Description

Megamitochondria

Data type

boolean

Alias
UMLS CUI [1,1]
C0549177
UMLS CUI [1,2]
C0026237
Mallory bodies
Description

Mallory bodies

Data type

boolean

Alias
UMLS CUI [1]
C0333744
"Ground Glass" inclusions
Description

Ground Glass inclusions

Data type

boolean

Alias
UMLS CUI [1]
C0598786
Lipofuscin pigment
Description

Lipofuscin pigment

Data type

boolean

Alias
UMLS CUI [1]
C0023789
Hemosiderin granules
Description

Hemosiderin granules

Data type

boolean

Alias
UMLS CUI [1,1]
C0019113
UMLS CUI [1,2]
C3853628
Orcein-positive cytoplasmin granules
Description

Orcein positive cytoplasmin granules

Data type

boolean

Alias
UMLS CUI [1,1]
C0069596
UMLS CUI [1,2]
C3853628
Protoporphyrin crystals (birefringent under polarised light)
Description

Protoporphyrin crystals

Data type

boolean

Alias
UMLS CUI [1,1]
C0033733
UMLS CUI [1,2]
C0444626
Uroporphyrin crystals (red fluorescence under ultraviolet light)
Description

Uroporphyrin crystals

Data type

boolean

Alias
UMLS CUI [1,1]
C0042093
UMLS CUI [1,2]
C0444626
Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0042219
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0227525
UMLS CUI [2,3]
C0007637
Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C0042219
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0227525
UMLS CUI [2,3]
C0007637
UMLS CUI [2,4]
C2348235
Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Hepatocyte or Liver Cell Nuclear Abnormalities

Alias
UMLS CUI-1
C0227525
UMLS CUI-2
C1849376
Hepatocyte or Liver Cell Nuclear Abnormalities
Description

If present, please check all that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
Hepatocellular mitosis
Description

Hepatocellular mitosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0026255
UMLS CUI [1,2]
C2697585
Binucleated or multinucleated hepatocytes
Description

Binucleated or multinucleated hepatocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C0333909
UMLS CUI [1,2]
C0227525
UMLS CUI [2]
C4054455
CMV inclusion bodies
Description

CMV inclusion bodies

Data type

boolean

Alias
UMLS CUI [1,1]
C0010825
UMLS CUI [1,2]
C0007637
HSV inclusions
Description

HSV inclusions

Data type

boolean

Alias
UMLS CUI [1,1]
C0319232
UMLS CUI [1,2]
C0007637
Varicella inclusions
Description

Varicella inclusions

Data type

boolean

Alias
UMLS CUI [1,1]
C0740380
UMLS CUI [1,2]
C0007637
Other Hepatocyte or Liver Cell Nuclear Abnormalities, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1849376
Other Hepatocyte or Liver Cell Nuclear Abnormalities, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0227525
UMLS CUI [1,3]
C1849376
UMLS CUI [1,4]
C2348235
Liver or Lobular Infiltrates
Description

Liver or Lobular Infiltrates

Alias
UMLS CUI-1
C0205417
UMLS CUI-2
C1400896
Liver or Lobular Infiltrates
Description

If present, check all that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [2]
C1400896
Eosinophils
Description

Liver or Lobular Infiltrates Eosinophils

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0014467
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0014467
Lymphocytes
Description

Liver or Lobular Infiltrates Lymphocytes

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0024264
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0024264
Plasma cells
Description

Liver or Lobular Infiltrates Plasma cells

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0032112
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0032112
Neutrophils
Description

Liver or Lobular Infiltrates Neutrophils

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0027950
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0027950
Macrophages and proliferating Kupffer cells
Description

Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0022801
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0022801
UMLS CUI [3,1]
C0205417
UMLS CUI [3,2]
C1400896
UMLS CUI [3,3]
C1168262
UMLS CUI [4,1]
C1400896
UMLS CUI [4,2]
C1168262
Granulomas
Description

Liver or Lobular Infiltrates Granulomas

Data type

boolean

Alias
UMLS CUI [1,1]
C0745754
UMLS CUI [1,2]
C0205417
UMLS CUI [2]
C0745754
Other Liver or Lobular Infiltrates, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0205394
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0205394
Other Liver or Lobular Infiltrates, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C1521902
UMLS CUI [2,1]
C1400896
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C1521902
Portal Tract Inflammation
Description

Portal Tract Inflammation

Alias
UMLS CUI-1
C3854488
Portal Tract Inflammation
Description

If present, check all that apply in following items

Data type

text

Alias
UMLS CUI [1]
C3854488
Eosinophils
Description

Eosinophils

Data type

boolean

Alias
UMLS CUI [1,1]
C0014467
UMLS CUI [1,2]
C3854488
Lymphoid aggregates and/or follicles
Description

Lymphoid aggregates and/or follicles

Data type

boolean

Alias
UMLS CUI [1,1]
C0229653
UMLS CUI [1,2]
C3854488
UMLS CUI [2,1]
C3854488
UMLS CUI [2,2]
C1518071
UMLS CUI [2,3]
C1571705
Plasma cells
Description

Plasma cells

Data type

boolean

Alias
UMLS CUI [1,1]
C0032112
UMLS CUI [1,2]
C3854488
Neutrophils
Description

Neutrophils

Data type

boolean

Alias
UMLS CUI [1,1]
C0027950
UMLS CUI [1,2]
C3854488
Histocytes and macrophages
Description

Histocytes and macrophages

Data type

boolean

Alias
UMLS CUI [1,1]
C0024432
UMLS CUI [1,2]
C3854488
UMLS CUI [2,1]
C3854488
UMLS CUI [2,2]
C0019612
Other Portal Tract Inflammation, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C3854488
UMLS CUI [1,2]
C0205394
Other Portal Tract Inflammation, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C3854488
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Bile Ducts
Description

Bile Ducts

Alias
UMLS CUI-1
C0005400
Bile Ducts
Description

If not normal, check all that apply in following items

Data type

text

Alias
UMLS CUI [1]
C0005400
Proliferation of bile ducts (bile ductular reaction)
Description

Proliferation of bile ducts

Data type

boolean

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0334094
Dilation, degeneration or disruption of portal bile ducts
Description

Dilation, degeneration or disruption of portal bile ducts

Data type

boolean

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0011164
UMLS CUI [2]
C1849767
UMLS CUI [3,1]
C0005400
UMLS CUI [3,2]
C0332453
Paucity of bile ducts
Description

Paucity of bile ducts

Data type

boolean

Alias
UMLS CUI [1]
C4273160
Periductal fibrosis
Description

Periductal fibrosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0016059
UMLS CUI [1,2]
C1282914
UMLS CUI [1,3]
C0005400
Other bile ducts, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0005400
Other bile ducts, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0005400
UMLS CUI [1,4]
C2348235
Portal Veins
Description

Portal Veins

Alias
UMLS CUI-1
C0032718
Portal Veins
Description

If not normal, check all that apply in following items

Data type

text

Alias
UMLS CUI [1]
C0032718
Pyelophlebitis
Description

Pyelophlebitis

Data type

boolean

Alias
UMLS CUI [1,1]
C1405883
UMLS CUI [1,2]
C0032718
Thrombosis, sclerosis or occlusion of portal vein
Description

Thrombosis, sclerosis or occlusion of portal vein

Data type

boolean

Alias
UMLS CUI [1]
C0155773
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C0036429
UMLS CUI [3]
C0265029
Neoplastic invasion of portal vein
Description

Neoplastic invasion of portal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C1709160
UMLS CUI [1,2]
C1510886
UMLS CUI [1,3]
C0032718
Granulomatous compression of portal vein
Description

Granulomatous compression of portal vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0439667
UMLS CUI [1,3]
C0728907
Other Portal veins, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1704258
Other Portal veins, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1704258
UMLS CUI [1,4]
C2348235
Liver Infections
Description

Liver Infections

Alias
UMLS CUI-1
C1112211
Liver Infections
Description

If present, check all that apply in following items

Data type

text

Alias
UMLS CUI [1]
C1112211
Leishmaniasis donovani
Description

Leishmaniasis donovani

Data type

boolean

Alias
UMLS CUI [1]
C0857306
Plasmodium falciparum
Description

Plasmodium falciparum

Data type

boolean

Alias
UMLS CUI [1]
C0032150
Toxoplasmosis
Description

Toxoplasmosis

Data type

boolean

Alias
UMLS CUI [1]
C0040558
Cryptococcus neoformans
Description

Cryptococcus neoformans

Data type

boolean

Alias
UMLS CUI [1]
C0010416
Histoplasma capsulatum
Description

Histoplasma capsulatum

Data type

boolean

Alias
UMLS CUI [1]
C0319941
Mycobacterium tuberculois
Description

Mycobacterium tuberculois

Data type

boolean

Alias
UMLS CUI [1]
C0026926
Other mycobacterial species
Description

Other mycobacterial species

Data type

boolean

Alias
UMLS CUI [1]
C1265234
Other Liver Infection, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1112211
Other Liver Infection, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1112211
UMLS CUI [1,3]
C2348235
Parasites or Ova
Description

Parasites or Ova

Alias
UMLS CUI-1
C0030498
UMLS CUI-2
C1267673
UMLS CUI-3
C0193388
Parasites or Ova
Description

If present, check all that apply in following items

Data type

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C1267673
UMLS CUI [2,2]
C0193388
Schistosome and/or ova
Description

Schistosome and/or ova

Data type

boolean

Alias
UMLS CUI [1,1]
C0036315
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C4303012
UMLS CUI [2,2]
C0193388
Ascaris and/or ova
Description

Ascaris and/or ova

Data type

boolean

Alias
UMLS CUI [1,1]
C3698183
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0003954
UMLS CUI [2,2]
C0193388
Toxocara and/or ova
Description

Toxocara and/or ova

Data type

boolean

Alias
UMLS CUI [1,1]
C0040550
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0040550
UMLS CUI [2,2]
C1267673
UMLS CUI [2,3]
C0193388
Echinococcus cysts
Description

Echinococcus cysts

Data type

boolean

Alias
UMLS CUI [1,1]
C0013502
UMLS CUI [1,2]
C0193388
Hepatic capillariasis worms and/or ova
Description

Hepatic capillariasis worms and/or ova

Data type

boolean

Alias
UMLS CUI [1,1]
C0277202
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0006896
UMLS CUI [2,2]
C1267673
UMLS CUI [2,3]
C0193388
Other Parasites or Ova, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C1267673
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0030498
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0193388
Other Parasites or Ova, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C1267673
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0030498
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0193388
UMLS CUI [2,4]
C2348235
Histologic Staining or Additional Studies Obtained
Description

Histologic Staining or Additional Studies Obtained

Alias
UMLS CUI-1
C0487602
UMLS CUI-2
C0193388
UMLS CUI-3
C1524062
UMLS CUI-4
C0430022
Haematoxylin and eosin (or H & E)
Description

Haematoxylin and eosin

Data type

boolean

Alias
UMLS CUI [1,1]
C0523207
UMLS CUI [1,2]
C0193388
Masson
Description

Masson

Data type

boolean

Alias
UMLS CUI [1,1]
C1294297
UMLS CUI [1,2]
C0193388
Toluidine blue or Giemsa
Description

Toluidine blue or Giemsa

Data type

boolean

Alias
UMLS CUI [1,1]
C0523203
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0017542
UMLS CUI [2,2]
C0193388
Prussian blue
Description

Prussian blue

Data type

boolean

Alias
UMLS CUI [1,1]
C1294004
UMLS CUI [1,2]
C0193388
Periodic Acidic Schiff (PAS), with or without diastase
Description

Periodic Acidic Schiff with or without diastase

Data type

boolean

Alias
UMLS CUI [1,1]
C0440048
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0440048
UMLS CUI [2,2]
C0193388
UMLS CUI [2,3]
C0002712
Oil red O
Description

Oil red O

Data type

boolean

Alias
UMLS CUI [1,1]
C1294000
UMLS CUI [1,2]
C0193388
Congo red
Description

Congo red

Data type

boolean

Alias
UMLS CUI [1,1]
C0009742
UMLS CUI [1,2]
C0193388
Hall's stain
Description

Hall's stain

Data type

boolean

Alias
UMLS CUI [1,1]
C1720394
UMLS CUI [1,2]
C0193388
Gridley's stain
Description

Gridley's stain

Data type

boolean

Alias
UMLS CUI [1,1]
C1293978
UMLS CUI [1,2]
C0193388
Rhodanine (copper)
Description

Rhodanine

Data type

boolean

Alias
UMLS CUI [1,1]
C0035486
UMLS CUI [1,2]
C0009968
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0193388
Rubeanic acid (copper)
Description

Rubeanic acid

Data type

boolean

Alias
UMLS CUI [1,1]
C0073680
UMLS CUI [1,2]
C0009968
UMLS CUI [1,3]
C0487602
UMLS CUI [1,4]
C0193388
Orcein, aldehyde fuchsin or Victoria blue
Description

Orcein, aldehyde fuchsin or Victoria blue

Data type

boolean

Alias
UMLS CUI [1,1]
C1294001
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C0491984
UMLS CUI [2,2]
C0193388
UMLS CUI [3,1]
C0078232
UMLS CUI [3,2]
C0487602
UMLS CUI [3,3]
C0193388
Electron microscopy
Description

Electron microscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0026019
UMLS CUI [1,2]
C0193388
Hepatitis A immunostains positive
Description

Hepatitis A immunostains positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0560226
UMLS CUI [1,2]
C3687908
UMLS CUI [1,3]
C0193388
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Description

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019166
UMLS CUI [1,2]
C3687908
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0369334
UMLS CUI [2,2]
C3687908
UMLS CUI [2,3]
C0193388
Hepatitis D immunostains
Description

Hepatitis D immunostains

Data type

boolean

Alias
UMLS CUI [1,1]
C0011226
UMLS CUI [1,2]
C3687908
UMLS CUI [1,3]
C0193388
Other immunostains
Description

Other immunostains

Data type

boolean

Alias
UMLS CUI [1,1]
C3687908
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0193388
Other Histologic Staining or Additional Studies Obtained, specify
Description

please specify

Data type

boolean

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0193388
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C1524062
UMLS CUI [2,3]
C0430022
UMLS CUI [2,4]
C0193388
Other Histologic Staining or Additional Studies Obtained, specify
Description

if applicable

Data type

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
UMLS CUI [2,3]
C1524062
UMLS CUI [2,4]
C0430022
UMLS CUI [2,5]
C0193388
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Similar models

Liver Biopsy

1 forms
  1. StudyEvent: ODM
    1. Liver Biopsy
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Liver biopsy number
Item
Liver biopsy number
integer
C0193388 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Date of liver biopsy
C0193388 (UMLS CUI-1)
C0011008 (UMLS CUI-2)
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Biopsy size
C1299482 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
Liver biopsy size
Item
Biopsy size
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Biopsy size unit
Item
Biopsy size unit [hidden]
text
C1299482 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Item Group
Final Diagnosis
C1546485 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
Item
Final Diagnosis
text
C1546485 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Final Diagnosis
Code List
Final Diagnosis
CL Item
Normal (A0)
CL Item
Check all that apply (AAA)
Acute hepatitis
Item
Acute hepatitis
boolean
C0267797 (UMLS CUI [1])
Chronic hepatitis
Item
Chronic hepatitis
boolean
C0019189 (UMLS CUI [1])
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
C0149904 (UMLS CUI [1])
Drug-induced cholestasis
Item
Drug-induced cholestasis
boolean
C2062350 (UMLS CUI [1])
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
C0276622 (UMLS CUI [1])
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
C0276623 (UMLS CUI [1])
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
C1262760 (UMLS CUI [1])
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
C0241910 (UMLS CUI [1])
Liver Bridging necrosis
Item
Bridging necrosis
boolean
C0333511 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
C0151798 (UMLS CUI [1])
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
C0001364 (UMLS CUI [1])
Steatosis - microvesicular
Item
Steatosis - microvesicular
boolean
C1850415 (UMLS CUI [1])
Steatosis - macrovesicular
Item
Steatosis - macrovesicular
boolean
C1837256 (UMLS CUI [1])
Steatosis - mixed
Item
Steatosis - mixed
boolean
C0015695 (UMLS CUI [1,1])
C0205430 (UMLS CUI [1,2])
Non-alcoholic steatohepatitis
Item
Non-alcoholic steatohepatitis
boolean
C3241937 (UMLS CUI [1])
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
C0019187 (UMLS CUI [1])
Hepatic granulomas
Item
Hepatic granulomas
boolean
C0745754 (UMLS CUI [1])
Liver Sarcoidosis
Item
Sarcoidosis
boolean
C0744822 (UMLS CUI [1])
Liver Fibrosis
Item
Fibrosis
boolean
C0239946 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
C0008312 (UMLS CUI [1])
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
C0566602 (UMLS CUI [1])
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
C2702837 (UMLS CUI [1])
Hemochromatosis
Item
Hemochromatosis
boolean
C0018995 (UMLS CUI [1])
Alpha-1-antitrypsin deficiency
Item
Alpha-1-antitrypsin deficiency
boolean
C0221757 (UMLS CUI [1])
Wilson's disease
Item
Wilson's disease
boolean
C0019202 (UMLS CUI [1])
Liver: Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0019156 (UMLS CUI [1])
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
C0856761 (UMLS CUI [1])
Liver Neoplasia
Item
Neoplasia
boolean
C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Other Final Diagnosis
Item
Other Final Diagnosis, specify
boolean
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Final Diagnosis specification
Item
Other Final Diagnosis, specify
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Liver Architecture
C0023884 (UMLS CUI-1)
C0935919 (UMLS CUI-2)
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
Check all that apply (BBB)
Bridging fibrosis
Item
Bridging fibrosis
boolean
C0334160 (UMLS CUI [1])
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
C0016059 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
C4048264 (UMLS CUI [1])
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
C0009714 (UMLS CUI [1])
Cirrhosis
Item
Cirrhosis
boolean
C0023890 (UMLS CUI [1])
Centrilobular congestion
Item
Centrilobular congestion
boolean
C0519014 (UMLS CUI [1])
Endophlebitis
Item
Endophlebitis
boolean
C0014234 (UMLS CUI [1])
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
C0948441 (UMLS CUI [1])
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
C3150342 (UMLS CUI [1])
Apoptosis
Item
Apoptosis
boolean
C0162638 (UMLS CUI [1])
Focal hepatocellular necrosis
Item
Focal (or spotty or mild ) hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
lnterface hepatitis
Item
lnterface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
C5139205 (UMLS CUI [1])
lschaemic necrosis
Item
lschaemic necrosis
boolean
C0027540 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
Centrolobular necrosis
Item
Centrolobular (Zone 3) necrosis
boolean
C0027540 (UMLS CUI [1,1])
C0682619 (UMLS CUI [1,2])
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
C1522058 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Centrolobular coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
C1522058 (UMLS CUI [1,1])
C0682619 (UMLS CUI [1,2])
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0333511 (UMLS CUI [1,2])
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
C1855038 (UMLS CUI [1,1])
C0522501 (UMLS CUI [1,2])
C1855038 (UMLS CUI [2,1])
C0442131 (UMLS CUI [2,2])
Dysplasia liver
Item
Dysplasia
boolean
C0334044 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Neoplasia liver
Item
Neoplasia
boolean
C1882062 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Other Liver Architecture
Item
Other Liver Architecture, specify
boolean
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify Other Liver Architecture
Item
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])
Item Group
Description of Liver Cells or Hepatocytes
C0227525 (UMLS CUI-1)
C0678257 (UMLS CUI-2)
Item
Description of Liver Cells or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Normal Hepatocytes
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (C0)
CL Item
Check all that apply (CCC)
Ballooning Hepatocytes
Item
Ballooning
boolean
C0333445 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
Acidophilic Hepatocytes
Item
Acidophilic
boolean
C0227525 (UMLS CUI [1,1])
C0333931 (UMLS CUI [1,2])
Pseudoxanthomatous Hepatocytes
Item
Pseudoxanthomatous
boolean
C0227525 (UMLS CUI [1,1])
C2348205 (UMLS CUI [1,2])
C1710694 (UMLS CUI [1,3])
Multinucleated giant hepatocytes
Item
Multinucleated giant hepatocytes
boolean
C1850414 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
Other Hepatocyte Description
Item
Other Description of Liver Cells or Hepatocytes, specify
boolean
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other Hepatocyte description specification
Item
Other Description of Liver Cells or Hepatocytes, specify
text
C1521902 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0678257 (UMLS CUI [1,4])
Item Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
C0227525 (UMLS CUI-1)
C0042219 (UMLS CUI-2)
C0007637 (UMLS CUI-3)
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C0227525 (UMLS CUI [2,1])
C0007637 (UMLS CUI [2,2])
Hepatocyte Inclusions or Vacuoles
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (D0)
CL Item
Check all that apply (DDD)
Macrovesicular steatosis
Item
Macrovesicular steatosis
boolean
C1837256 (UMLS CUI [1])
Microvesicular steatosis
Item
Microvesicular steatosis
boolean
C1850415 (UMLS CUI [1])
Bile accumulation
Item
Bile accumulation
boolean
C3686784 (UMLS CUI [1])
Diastase-resistant, PAS-positive cytoplasmic inclusions
Item
Diastase-resistant, PAS-positive cytoplasmic inclusions
boolean
C1856311 (UMLS CUI [1])
Alpha-1-antitrypsin inclusions
Item
Alpha-1-antitrypsin inclusions
boolean
C0002191 (UMLS CUI [1,1])
C0007637 (UMLS CUI [1,2])
Megamitochondria
Item
Megamitochondria
boolean
C0549177 (UMLS CUI [1,1])
C0026237 (UMLS CUI [1,2])
Mallory bodies
Item
Mallory bodies
boolean
C0333744 (UMLS CUI [1])
Ground Glass inclusions
Item
"Ground Glass" inclusions
boolean
C0598786 (UMLS CUI [1])
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
C0023789 (UMLS CUI [1])
Hemosiderin granules
Item
Hemosiderin granules
boolean
C0019113 (UMLS CUI [1,1])
C3853628 (UMLS CUI [1,2])
Orcein positive cytoplasmin granules
Item
Orcein-positive cytoplasmin granules
boolean
C0069596 (UMLS CUI [1,1])
C3853628 (UMLS CUI [1,2])
Protoporphyrin crystals
Item
Protoporphyrin crystals (birefringent under polarised light)
boolean
C0033733 (UMLS CUI [1,1])
C0444626 (UMLS CUI [1,2])
Uroporphyrin crystals
Item
Uroporphyrin crystals (red fluorescence under ultraviolet light)
boolean
C0042093 (UMLS CUI [1,1])
C0444626 (UMLS CUI [1,2])
Other Hepatocyte Inclusions or Vacuoles
Item
Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify
boolean
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C0227525 (UMLS CUI [2,2])
C0007637 (UMLS CUI [2,3])
Other Hepatocyte Inclusions or Vacuoles Specification
Item
Other Liver Cell or Hepatocyte Inclusions or Vacuoles, specify
text
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C0042219 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C0227525 (UMLS CUI [2,2])
C0007637 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
C0227525 (UMLS CUI-1)
C1849376 (UMLS CUI-2)
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Hepatocyte Nuclear Abnormalities
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (E0)
CL Item
Check all that apply (EEE)
Hepatocellular mitosis
Item
Hepatocellular mitosis
boolean
C0026255 (UMLS CUI [1,1])
C2697585 (UMLS CUI [1,2])
Binucleated or multinucleated hepatocytes
Item
Binucleated or multinucleated hepatocytes
boolean
C0333909 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C4054455 (UMLS CUI [2])
CMV inclusion bodies
Item
CMV inclusion bodies
boolean
C0010825 (UMLS CUI [1,1])
C0007637 (UMLS CUI [1,2])
HSV inclusions
Item
HSV inclusions
boolean
C0319232 (UMLS CUI [1,1])
C0007637 (UMLS CUI [1,2])
Varicella inclusions
Item
Varicella inclusions
boolean
C0740380 (UMLS CUI [1,1])
C0007637 (UMLS CUI [1,2])
Other Hepatocyte Nuclear Abnormalities
Item
Other Hepatocyte or Liver Cell Nuclear Abnormalities, specify
boolean
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
Other Hepatocyte Nuclear Abnormalities Specification
Item
Other Hepatocyte or Liver Cell Nuclear Abnormalities, specify
text
C0205394 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Liver or Lobular Infiltrates
C0205417 (UMLS CUI-1)
C1400896 (UMLS CUI-2)
Item
Liver or Lobular Infiltrates
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C1400896 (UMLS CUI [2])
Liver or Lobular Infiltrates
Code List
Liver or Lobular Infiltrates
CL Item
None (F0)
CL Item
Check all that apply (FFF)
Liver or Lobular Infiltrates Eosinophils
Item
Eosinophils
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0014467 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0014467 (UMLS CUI [2,2])
Liver or Lobular Infiltrates Lymphocytes
Item
Lymphocytes
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0024264 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0024264 (UMLS CUI [2,2])
Liver or Lobular Infiltrates Plasma cells
Item
Plasma cells
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0032112 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0032112 (UMLS CUI [2,2])
Liver or Lobular Infiltrates Neutrophils
Item
Neutrophils
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0027950 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0027950 (UMLS CUI [2,2])
Liver or Lobular Infiltrates Macrophages and proliferating Kupffer cells
Item
Macrophages and proliferating Kupffer cells
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0022801 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0022801 (UMLS CUI [2,2])
C0205417 (UMLS CUI [3,1])
C1400896 (UMLS CUI [3,2])
C1168262 (UMLS CUI [3,3])
C1400896 (UMLS CUI [4,1])
C1168262 (UMLS CUI [4,2])
Liver or Lobular Infiltrates Granulomas
Item
Granulomas
boolean
C0745754 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0745754 (UMLS CUI [2])
Other Liver or Lobular Infiltrates
Item
Other Liver or Lobular Infiltrates, specify
boolean
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1400896 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Other Liver or Lobular Infiltrates specification
Item
Other Liver or Lobular Infiltrates, specify
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C1400896 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Item Group
Portal Tract Inflammation
C3854488 (UMLS CUI-1)
Item
Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
Portal Tract Inflammation
Code List
Portal Tract Inflammation
CL Item
None (G0)
CL Item
Check all that apply (GGG)
Eosinophils
Item
Eosinophils
boolean
C0014467 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Lymphoid aggregates and/or follicles
Item
Lymphoid aggregates and/or follicles
boolean
C0229653 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [2,1])
C1518071 (UMLS CUI [2,2])
C1571705 (UMLS CUI [2,3])
Plasma cells
Item
Plasma cells
boolean
C0032112 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Neutrophils
Item
Neutrophils
boolean
C0027950 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
Histocytes and macrophages
Item
Histocytes and macrophages
boolean
C0024432 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
C3854488 (UMLS CUI [2,1])
C0019612 (UMLS CUI [2,2])
Other Portal Tract Inflammation
Item
Other Portal Tract Inflammation, specify
boolean
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other Portal Tract Inflammation specification
Item
Other Portal Tract Inflammation, specify
text
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Bile Ducts
C0005400 (UMLS CUI-1)
Item
Bile Ducts
text
C0005400 (UMLS CUI [1])
Bile Ducts normal
Code List
Bile Ducts
CL Item
Normal (H0)
CL Item
Check all that apply (HHH)
Proliferation of bile ducts
Item
Proliferation of bile ducts (bile ductular reaction)
boolean
C0005400 (UMLS CUI [1,1])
C0334094 (UMLS CUI [1,2])
Dilation, degeneration or disruption of portal bile ducts
Item
Dilation, degeneration or disruption of portal bile ducts
boolean
C0005400 (UMLS CUI [1,1])
C0011164 (UMLS CUI [1,2])
C1849767 (UMLS CUI [2])
C0005400 (UMLS CUI [3,1])
C0332453 (UMLS CUI [3,2])
Paucity of bile ducts
Item
Paucity of bile ducts
boolean
C4273160 (UMLS CUI [1])
Periductal fibrosis
Item
Periductal fibrosis
boolean
C0016059 (UMLS CUI [1,1])
C1282914 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,3])
Other Bile ducts abnormality
Item
Other bile ducts, specify
boolean
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,3])
Other Bile ducts abnormality specification
Item
Other bile ducts, specify
text
C0205394 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0005400 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Portal Veins
C0032718 (UMLS CUI-1)
Item
Portal Veins
text
C0032718 (UMLS CUI [1])
Portal Veins
Code List
Portal Veins
CL Item
Normal (I0)
CL Item
Check all that apply (III)
Pyelophlebitis
Item
Pyelophlebitis
boolean
C1405883 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
Thrombosis, sclerosis or occlusion of portal vein
Item
Thrombosis, sclerosis or occlusion of portal vein
boolean
C0155773 (UMLS CUI [1])
C0032718 (UMLS CUI [2,1])
C0036429 (UMLS CUI [2,2])
C0265029 (UMLS CUI [3])
Neoplastic invasion of portal vein
Item
Neoplastic invasion of portal vein
boolean
C1709160 (UMLS CUI [1,1])
C1510886 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
Granulomatous compression of portal vein
Item
Granulomatous compression of portal vein
boolean
C0032718 (UMLS CUI [1,1])
C0439667 (UMLS CUI [1,2])
C0728907 (UMLS CUI [1,3])
Other Portal veins Abnormality
Item
Other Portal veins, specify
boolean
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Other Portal veins Abnormality specification
Item
Other Portal veins, specify
text
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Liver Infections
C1112211 (UMLS CUI-1)
Item
Liver Infections
text
C1112211 (UMLS CUI [1])
Liver Infections
Code List
Liver Infections
CL Item
Normal (J0)
CL Item
Check all that apply (JJJ)
Leishmaniasis donovani
Item
Leishmaniasis donovani
boolean
C0857306 (UMLS CUI [1])
Plasmodium falciparum
Item
Plasmodium falciparum
boolean
C0032150 (UMLS CUI [1])
Toxoplasmosis
Item
Toxoplasmosis
boolean
C0040558 (UMLS CUI [1])
Cryptococcus neoformans
Item
Cryptococcus neoformans
boolean
C0010416 (UMLS CUI [1])
Histoplasma capsulatum
Item
Histoplasma capsulatum
boolean
C0319941 (UMLS CUI [1])
Mycobacterium tuberculois
Item
Mycobacterium tuberculois
boolean
C0026926 (UMLS CUI [1])
Other mycobacterial species
Item
Other mycobacterial species
boolean
C1265234 (UMLS CUI [1])
Other Liver Infection
Item
Other Liver Infection, specify
boolean
C0205394 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
Other Liver Infection specification
Item
Other Liver Infection, specify
text
C0205394 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Parasites or Ova
C0030498 (UMLS CUI-1)
C1267673 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
Item
Parasites or Ova
text
C0030498 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C1267673 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Parasites or ova in liver biopsy
Code List
Parasites or Ova
CL Item
None (K0)
CL Item
Check all that apply (KKK)
Schistosome and/or ova
Item
Schistosome and/or ova
boolean
C0036315 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C4303012 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Ascaris and/or ova
Item
Ascaris and/or ova
boolean
C3698183 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0003954 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Toxocara and/or ova
Item
Toxocara and/or ova
boolean
C0040550 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0040550 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Echinococcus cysts
Item
Echinococcus cysts
boolean
C0013502 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Hepatic capillariasis worms and/or ova
Item
Hepatic capillariasis worms and/or ova
boolean
C0277202 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0006896 (UMLS CUI [2,1])
C1267673 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Other Parasites or Ova in liver biopsy
Item
Other Parasites or Ova, specify
boolean
C1267673 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0030498 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Other Parasites or Ova in liver biopsy specification
Item
Other Parasites or Ova, specify
text
C1267673 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0030498 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item Group
Histologic Staining or Additional Studies Obtained
C0487602 (UMLS CUI-1)
C0193388 (UMLS CUI-2)
C1524062 (UMLS CUI-3)
C0430022 (UMLS CUI-4)
Haematoxylin and eosin
Item
Haematoxylin and eosin (or H & E)
boolean
C0523207 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Masson
Item
Masson
boolean
C1294297 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Toluidine blue or Giemsa
Item
Toluidine blue or Giemsa
boolean
C0523203 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0017542 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
Prussian blue
Item
Prussian blue
boolean
C1294004 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Periodic Acidic Schiff with or without diastase
Item
Periodic Acidic Schiff (PAS), with or without diastase
boolean
C0440048 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0440048 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0002712 (UMLS CUI [2,3])
Oil red O
Item
Oil red O
boolean
C1294000 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Congo red
Item
Congo red
boolean
C0009742 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Hall's stain
Item
Hall's stain
boolean
C1720394 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Gridley's stain
Item
Gridley's stain
boolean
C1293978 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Rhodanine
Item
Rhodanine (copper)
boolean
C0035486 (UMLS CUI [1,1])
C0009968 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
Rubeanic acid
Item
Rubeanic acid (copper)
boolean
C0073680 (UMLS CUI [1,1])
C0009968 (UMLS CUI [1,2])
C0487602 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
Orcein, aldehyde fuchsin or Victoria blue
Item
Orcein, aldehyde fuchsin or Victoria blue
boolean
C1294001 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C0491984 (UMLS CUI [2,1])
C0193388 (UMLS CUI [2,2])
C0078232 (UMLS CUI [3,1])
C0487602 (UMLS CUI [3,2])
C0193388 (UMLS CUI [3,3])
Electron microscopy
Item
Electron microscopy
boolean
C0026019 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Hepatitis A immunostains positive
Item
Hepatitis A immunostains positive
boolean
C0560226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
C0019166 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0369334 (UMLS CUI [2,1])
C3687908 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Hepatitis D immunostains
Item
Hepatitis D immunostains
boolean
C0011226 (UMLS CUI [1,1])
C3687908 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Other immunostains
Item
Other immunostains
boolean
C3687908 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Other Histologic Staining of Liver Biopsy or Additional Studies Obtained
Item
Other Histologic Staining or Additional Studies Obtained, specify
boolean
C0487602 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0205394 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0430022 (UMLS CUI [2,3])
C0193388 (UMLS CUI [2,4])
Other Histologic Staining of Liver Biopsy or Additional Studies Obtained specification
Item
Other Histologic Staining or Additional Studies Obtained, specify
text
C0487602 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1524062 (UMLS CUI [2,3])
C0430022 (UMLS CUI [2,4])
C0193388 (UMLS CUI [2,5])
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