ID

38557

Description

Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Keywords

Versions (2)
  1. 10/20/19 10/20/19 -
  2. 10/24/19 10/24/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 24, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636

English

Liver Event Details

1 forms  
  1. StudyEvent: ODM
    1. Liver Event Details
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient name

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patients, Identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C1320303
UMLS CUI-4
C2985720
Date of visit/assessment
Description

Liver, Adverse Event, Date of visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1320303
UMLS CUI [1,4]
C2985720
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Description

Liver, Adverse Event, Liver function, Chemistry, Clinical

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0232741
UMLS CUI [1,4]
C0008000
Is the subject age 55 or older?
Description

Liver, Adverse Event, Age

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0001779
If female, is the subject pregnant?
Description

Liver, Adverse Event, Pregnancy

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

Liver, Adverse Event, Diagnostic Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0011923
If Yes, were the results normal?
Description

Liver, Adverse Event, Diagnostic Imaging, Result

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0011923
UMLS CUI [1,4]
C1274040
Were any liver biopsies performed?
Description

Liver, Adverse Event, Biopsy of liver

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

Liver, Adverse Event, Herbal medicine; Liver,Adverse event, Complementary Medicine; Liver, Adverse event, Alternative Medicine; Liver, Adverse event, Dietary Supplements; Liver, Adverse event, Illicit medication use

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2240391
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C1148474
UMLS CUI [3,1]
C0023884
UMLS CUI [3,2]
C0877248
UMLS CUI [3,3]
C0002346
UMLS CUI [4,1]
C0023884
UMLS CUI [4,2]
C0877248
UMLS CUI [4,3]
C0242295
UMLS CUI [5,1]
C0023884
UMLS CUI [5,2]
C0877248
UMLS CUI [5,3]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

Liver, Adverse Event, Fasting; Liver, Adverse event, Change in diet

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0015663
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C3671772
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0304229
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - Start Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - Start Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, Start Date

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - End Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0806020
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - End Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, End Date

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0806020
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - Start Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - Start Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, Start Date

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0808070
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - End Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0806020
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - End Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, End Date

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0806020
Alcohol Intake
Description

Alcohol Intake

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0001948
Does the subject consume alcohol?
Description

Liver, Adverse Event, Alcohol consumption

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0001948
Yes, record the average number of units of alcohol consumed per week
Description

Liver, Adverse Event, Alcohol consumption, alcohol units/week

Data type

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0001948C0560579
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0012634
Acute Viral Hepatitis A
Description

Liver, Adverse Event, Disease, Acute type A viral hepatitis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0276434
Chronic Hepatitis B
Description

Liver, Adverse Event, Disease, Hepatitis B, Chronic

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0524909
Chronic Hepatitis C
Description

Liver, Adverse Event, Disease, Hepatitis C, Chronic

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0524910
Cytomegalovirus Hepatitis
Description

Liver, Adverse Event, Disease, Cytomegalovirus hepatitis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Description

Liver, Adverse Event, Disease, Infectious Mononucleosis, Epstein-Barr Virus

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0021345
UMLS CUI [1,5]
C0014644
Herpes Simplex Hepatitis
Description

Liver, Adverse Event, Disease, Herpes simplex hepatitis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C1963747
Alcoholic Liver Disease
Description

Liver, Adverse Event, Disease, Alcoholic Liver Diseases

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0023896
Non-alcoholic Steatohepatitis
Description

Liver, Adverse Event, Disease, Nonalcoholic Steatohepatitis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C3241937
Fatty Liver
Description

Liver, Adverse Event, Disease, Fatty Liver

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0015695
Hepatic Cirrhosis
Description

Liver, Adverse Event, Disease, Liver Cirrhosis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0023890
Hemochromatosis
Description

Liver, Adverse Event, Disease, Hemochromatosis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0018995
Autoimmune Hepatitis
Description

Liver, Adverse Event, Disease, Hepatitis, Autoimmune

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0241910
Gallbladder disease
Description

Liver, Adverse Event, Disease, Gall Bladder Diseases

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0016977
Drug related liver disease
Description

Liver, Adverse Event, Disease, Drug-related disorder

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C0016977
UMLS CUI [1,5]
C0277579
Other Liver Disease Conditions
Description

Other Liver Disease Conditions

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0023895
UMLS CUI-4
C0205394
Sequence Number
Description

Liver, Adverse Event, Liver diseases, Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C2348184
Specific Condition
Description

Liver, Adverse Event, Liver diseases

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
Modified Term
Description

Liver, Adverse Event, Liver diseases, Adverse Event Modified Reported Term

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C2826798
MedDRA Synonym
Description

Liver, Adverse Event, Liver diseases, Medical Dictionary for Regulatory Activities Terminology (MedDRA)

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C1140263
MedDRA lower level term code
Description

Liver, Adverse Event, Liver diseases, MedDRA Low Level Term Code

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C3898442
Failed coding
Description

Liver, Adverse Event, Liver diseases, Code, Failed

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C0805701
UMLS CUI [1,5]
C0231175
Status
Description

Liver, Adverse Event, Liver diseases, Status

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0023895
UMLS CUI [1,4]
C0449438
Other Medical Conditions
Description

Other Medical Conditions

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0012634
UMLS CUI-4
C0205394
Drug Allergies
Description

Liver, Adverse Event, Pharmaceutical Preparations, Hypersensitivity

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0020517
Rheumatoid Arthritis
Description

Liver, Adverse Event, Rheumatoid Arthritis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0003873
Psoriasis
Description

Liver, Adverse Event, Psoriasis

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0033860
Thyroid Disease
Description

Liver, Adverse Event, Thyroid Diseases

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0040128
Inflammatory Bowel Disease
Description

Liver, Adverse Event, Inflammatory Bowel Diseases

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0021390
Lupus
Description

Liver, Adverse Event, Lupus Erythematosus

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0409974
Sjogren's Syndrome
Description

Liver, Adverse Event, Sjogren's Syndrome

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1527336
Vitiligo
Description

Liver, Adverse Event, Vitiligo

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0042900
Pharmacokinetics
Description

Pharmacokinetics

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0031328
Was a pharmacokinetic blood sample obtained?
Description

Liver, Adverse Event, Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0031328
UMLS CUI [1,4]
C0005834
Yes, date and time sample taken
Description

Liver, Adverse Event, Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0031328
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0040223
If Yes, date and time of last investigational product dose prior to PK sample
Description

Liver, Adverse Event, Pharmacokinetic aspects, Drug dose, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0031328
UMLS CUI [1,4]
C0678766
UMLS CUI [1,5]
C0011008
UMLS CUI [1,6]
C0040223
Sample Identifier/Sample Number
Description

Liver, Adverse Event, Pharmacokinetic aspects, Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0031328
UMLS CUI [1,4]
C1299222
Liver Imaging
Description

Liver Imaging

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C2711860
Date of hepatic or liver imaging test
Description

Liver, Adverse Event, Imaging of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0011008
What method was used for this imaging test?
Description

Liver, Adverse Event, Imaging of liver, Imaging modality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C1275506
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Imaging modality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C1275506
Are images technically adequate?
Description

Liver, Adverse Event, Imaging of liver, Quality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0332306
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Quality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0332306
Indicate the liver size
Description

Liver, Adverse Event, Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0426688
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0426688
Indicate the liver texture
Description

Liver, Adverse Event, Imaging of liver, Texture Perception

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0679033
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Texture Perceiption

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0679033
Grade the diffuse and/or geographic fatty infiltrate of the liver
Description

Liver, Adverse Event, Imaging of liver, Fatty Liver, Grade

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0015695
UMLS CUI [1,5]
C0441800
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Fatty Liver, Grade

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0015695
UMLS CUI [1,5]
C0441800
Ascites present
Description

Liver, Adverse Event, Imaging of liver, Ascites

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0003962
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Ascites

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0003962
Are Focal Hepatic Lesions characterisable?
Description

Liver, Adverse Event, Imaging of liver, Lesion of liver, Focal

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0577053
UMLS CUI [1,5]
C0205234
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Lesion of liver, Focal

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0577053
UMLS CUI [1,5]
C0205234
Gallstones or gallbladder lesions?
Description

Liver, Adverse Event, Imaging of liver, Gallstones/gallbladder problems, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C3842395
UMLS CUI [1,5]
C0221198
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Gallstones/gallbladder problems, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C3842395
UMLS CUI [1,5]
C0221198
Biliary ductal lesions?
Description

Liver, Adverse Event, Imaging of liver, Biliary tract structure, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0005423
UMLS CUI [1,5]
C0221198
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Biliary tract structure, Lesion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0005423
UMLS CUI [1,5]
C0221198
Portal/Hepatic vein abnormalities?
Description

Liver, Adverse Event, Imaging of liver, Structure of hepatic vein, Abnormality; Liver, Adverse Event, Imaging of liver, Portal vein structure, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0019155
UMLS CUI [1,5]
C1704258
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C2711860
UMLS CUI [2,4]
C0032718
UMLS CUI [2,5]
C1704258
Other, specify
Description

Liver, Adverse Event, Imaging of liver, Structure of hepatic vein, Abnormality; Liver, Adverse Event, Imaging of liver, Portal vein structure, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2711860
UMLS CUI [1,4]
C0019155
UMLS CUI [1,5]
C1704258
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C2711860
UMLS CUI [2,4]
C0032718
UMLS CUI [2,5]
C1704258
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0193388
Date of liver biopsy
Description

Liver, Adverse Event, Biopsy of liver, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0011008
Approximate size of liver biopsy
Description

Liver, Adverse Event, Biopsy of liver, Specimen size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1299482
mm
Biopsy size unit
Description

Liver, Adverse Event, Biopsy of liver, Specimen size, Unit of Measure

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1299482
UMLS CUI [1,5]
C1519795
Final Diagnosis
Description

Liver, Adverse Event, Biopsy of liver, Diagnosis Type - Final

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1546485
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Diagnosis Type - Final

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1546485
Liver Architecture
Description

Liver, Adverse Event, Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0935919
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Cellular structure aspects

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0935919
Description of Liver Cells or Hepatocytes
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Description

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C0678257
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Description

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C0678257
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Vacuole, Inclusion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C0042219
UMLS CUI [1,6]
C1512693
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Vacuole, Inclusion

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C0042219
UMLS CUI [1,6]
C1512693
Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Abnormal nuclear morphology

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C1849376
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Hepatocyte, Abnormal nuclear morphology

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0227525
UMLS CUI [1,5]
C1849376
Liver or Lobular Infiltrates
Description

Liver, Adverse Event, Biopsy of liver, Infiltrate

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0205417
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Infiltrate

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0205417
Portal Tract Inflammation
Description

Liver, Adverse Event, Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C3854488
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C3854488
Bile Ducts
Description

Liver, Adverse Event, Biopsy of liver, Bile duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0005400
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Bile duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0005400
Portal Veins
Description

Liver, Adverse Event, Biopsy of liver, Portal vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0032718
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Portal vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0032718
Liver Infections
Description

Liver, Adverse Event, Biopsy of liver, Hepatic infection

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1112211
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Hepatic infection

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C1112211
Parasites or Ova
Description

Liver, Adverse Event, Biopsy of liver, Parasite, Ovum of parasite

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0030498
UMLS CUI [1,5]
C1267673
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Parasite, Ovum of parasite

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0030498
UMLS CUI [1,5]
C1267673
Histologic Staining or Additional Studies Obtained
Description

Liver, Adverse Event, Biopsy of liver, Staining method; Liver, Adverse Event, Biopsy of liver, Study Subject Participation Status

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0487602
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C0193388
UMLS CUI [2,4]
C2348568
Other, specify
Description

Liver, Adverse Event, Biopsy of liver, Staining method; Liver, Adverse Event, Biopsy of liver, Study Subject Participation Status

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0193388
UMLS CUI [1,4]
C0487602
UMLS CUI [2,1]
C0023884
UMLS CUI [2,2]
C0877248
UMLS CUI [2,3]
C0193388
UMLS CUI [2,4]
C2348568
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Similar models

Liver Event Details

1 forms
  1. StudyEvent: ODM
    1. Liver Event Details
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient name
Item
Patient
text
C1299487 (UMLS CUI [1])
Patients, Identification number
Item
Patient No
integer
C0030705 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Date of Visit/Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1320303 (UMLS CUI-3)
C2985720 (UMLS CUI-4)
Liver, Adverse Event, Date of visit, Assessment Date
Item
Date of visit/assessment
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,4])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,4])
Liver, Adverse Event, Liver function, Chemistry, Clinical
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase)  (1)
CL Item
AST (aspartate aminotransferase)  (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
Other (5)
Liver, Adverse Event, Age
Item
Is the subject age 55 or older?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Item
If female, is the subject pregnant?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
Liver, Adverse Event, Pregnancy
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not applicable (3)
Liver, Adverse Event, Diagnostic Imaging
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Liver, Adverse Event, Diagnostic Imaging, Result
Item
If Yes, were the results normal?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Liver, Adverse Event, Biopsy of liver
Item
Were any liver biopsies performed?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Liver, Adverse Event, Herbal medicine; Liver,Adverse event, Complementary Medicine; Liver, Adverse event, Alternative Medicine; Liver, Adverse event, Dietary Supplements; Liver, Adverse event, Illicit medication use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2240391 (UMLS CUI [1,3])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C1148474 (UMLS CUI [2,3])
C0023884 (UMLS CUI [3,1])
C0877248 (UMLS CUI [3,2])
C0002346 (UMLS CUI [3,3])
C0023884 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
C0242295 (UMLS CUI [4,3])
C0023884 (UMLS CUI [5,1])
C0877248 (UMLS CUI [5,2])
C0281875 (UMLS CUI [5,3])
Liver, Adverse Event, Fasting; Liver, Adverse event, Change in diet
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,3])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C3671772 (UMLS CUI [2,3])
Item Group
Investigational Product (Liver)
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Liver, Adverse Event, Experimental drug, Start Date
Item
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - Start Date Investigational Product
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - Start Date Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Liver, Adverse Event, Experimental drug, Start Date
Code List
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - Start Date Investigational Product
CL Item
Not applicable (1)
Liver, Adverse Event, Experimental drug, End Date
Item
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - End Date Investigational Product
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Item
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - End Date Investigational Product
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Liver, Adverse Event, Experimental drug, End Date
Code List
If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. - End Date Investigational Product
CL Item
Not applicable (1)
Liver, Adverse Event, Experimental drug, Start Date
Item
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - Start Date Investigational Product
date
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Item
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - Start Date Investigational Product
text
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Liver, Adverse Event, Experimental drug, Start Date
Code List
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - Start Date Investigational Product
CL Item
Not applicable (1)
Liver, Adverse Event, Experimental drug, End Date
Item
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - End Date Investigational Product
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Item
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - End Date Investigational Product
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Liver, Adverse Event, Experimental drug, End Date
Code List
If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. - End Date Investigational Product
CL Item
Not applicable (1)
Item Group
Alcohol Intake
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0001948 (UMLS CUI-3)
Liver, Adverse Event, Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
Liver, Adverse Event, Alcohol consumption, alcohol units/week
Item
Yes, record the average number of units of alcohol consumed per week
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0001948C0560579 (UMLS CUI [1,3])
Item Group
Medical Conditions
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Item
Acute Viral Hepatitis A
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0276434 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Acute type A viral hepatitis
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis B
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0524909 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Hepatitis B, Chronic
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0524910 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Hepatitis C, Chronic
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0276252 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Cytomegalovirus hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0021345 (UMLS CUI [1,4])
C0014644 (UMLS CUI [1,5])
Liver, Adverse Event, Disease, Infectious Mononucleosis, Epstein-Barr Virus
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Herpes Simplex Hepatitis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1963747 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Herpes simplex hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0023896 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Alcoholic Liver Diseases
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Non-alcoholic Steatohepatitis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C3241937 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Nonalcoholic Steatohepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Fatty Liver
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0015695 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Fatty Liver
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0023890 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Liver Cirrhosis
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hemochromatosis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0018995 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Hemochromatosis
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0241910 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Hepatitis, Autoimmune
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0016977 (UMLS CUI [1,4])
Liver, Adverse Event, Disease, Gall Bladder Diseases
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0016977 (UMLS CUI [1,4])
C0277579 (UMLS CUI [1,5])
Liver, Adverse Event, Disease, Drug-related disorder
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other Liver Disease Conditions
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0023895 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Liver, Adverse Event, Liver diseases, Sequence Number
Item
Sequence Number
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,4])
Liver, Adverse Event, Liver diseases
Item
Specific Condition
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
Liver, Adverse Event, Liver diseases, Adverse Event Modified Reported Term
Item
Modified Term
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C2826798 (UMLS CUI [1,4])
Liver, Adverse Event, Liver diseases, Medical Dictionary for Regulatory Activities Terminology (MedDRA)
Item
MedDRA Synonym
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1140263 (UMLS CUI [1,4])
Liver, Adverse Event, Liver diseases, MedDRA Low Level Term Code
Item
MedDRA lower level term code
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C3898442 (UMLS CUI [1,4])
Liver, Adverse Event, Liver diseases, Code, Failed
Item
Failed coding
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,4])
C0231175 (UMLS CUI [1,5])
Item
Status
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,4])
Liver, Adverse Event, Liver diseases, Status
Code List
Status
CL Item
Current  (1)
CL Item
Past (2)
Item Group
Other Medical Conditions
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
C0205394 (UMLS CUI-4)
Item
Drug Allergies
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,4])
Liver, Adverse Event, Pharmaceutical Preparations, Hypersensitivity
Code List
Drug Allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
Liver, Adverse Event, Rheumatoid Arthritis
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psoriasis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0033860 (UMLS CUI [1,3])
Liver, Adverse Event, Psoriasis
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid Disease
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0040128 (UMLS CUI [1,3])
Liver, Adverse Event, Thyroid Diseases
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0021390 (UMLS CUI [1,3])
Liver, Adverse Event, Inflammatory Bowel Diseases
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Lupus
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0409974 (UMLS CUI [1,3])
Liver, Adverse Event, Lupus Erythematosus
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Sjogren's Syndrome
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1527336 (UMLS CUI [1,3])
Liver, Adverse Event, Sjogren's Syndrome
Code List
Sjogren's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vitiligo
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0042900 (UMLS CUI [1,3])
Liver, Adverse Event, Vitiligo
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Pharmacokinetics
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0031328 (UMLS CUI-3)
Liver, Adverse Event, Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
Liver, Adverse Event, Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Date in time, Time
Item
Yes, date and time sample taken
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0040223 (UMLS CUI [1,6])
Liver, Adverse Event, Pharmacokinetic aspects, Drug dose, Date in time, Time
Item
If Yes, date and time of last investigational product dose prior to PK sample
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0678766 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0040223 (UMLS CUI [1,6])
Liver, Adverse Event, Pharmacokinetic aspects, Sample identification number
Item
Sample Identifier/Sample Number
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,4])
Item Group
Liver Imaging
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C2711860 (UMLS CUI-3)
Liver, Adverse Event, Imaging of liver, Date in time
Item
Date of hepatic or liver imaging test
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item
What method was used for this imaging test?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C1275506 (UMLS CUI [1,4])
Imaging of liver, Imaging modality
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 (8)
Liver, Adverse Event, Imaging of liver, Imaging modality
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C1275506 (UMLS CUI [1,4])
Item
Are images technically adequate?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0332306 (UMLS CUI [1,4])
Imaging of liver, Quality
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 (4)
Liver, Adverse Event, Imaging of liver, Quality
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0332306 (UMLS CUI [1,4])
Item
Indicate the liver size
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0426688 (UMLS CUI [1,4])
Imaging of liver, Liver size
Code List
Indicate the liver size
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)
Liver, Adverse Event, Imaging of liver, Liver size
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0426688 (UMLS CUI [1,4])
Item
Indicate the liver texture
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0679033 (UMLS CUI [1,4])
Imaging of liver, Texture Perception
Code List
Indicate the liver texture
CL Item
Normal (1)
CL Item
Heterogenous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Liver, Adverse Event, Imaging of liver, Texture Perceiption
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0679033 (UMLS CUI [1,4])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0015695 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,5])
Imaging of liver, Fatty Liver, Grade
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)
Liver, Adverse Event, Imaging of liver, Fatty Liver, Grade
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0015695 (UMLS CUI [1,4])
C0441800 (UMLS CUI [1,5])
Item
Ascites present
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0003962 (UMLS CUI [1,4])
Imaging of liver, Ascites
Code List
Ascites present
CL Item
None present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (4)
Liver, Adverse Event, Imaging of liver, Ascites
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0003962 (UMLS CUI [1,4])
Item
Are Focal Hepatic Lesions characterisable?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0577053 (UMLS CUI [1,4])
C0205234 (UMLS CUI [1,5])
Imaging of liver, Lesion of liver, Focal
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions  (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (6)
Liver, Adverse Event, Imaging of liver, Lesion of liver, Focal
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0577053 (UMLS CUI [1,4])
C0205234 (UMLS CUI [1,5])
Item
Gallstones or gallbladder lesions?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C3842395 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,5])
Imaging of liver, Gallstones/gallbladder problems, Lesion
Code List
Gallstones or gallbladder lesions?
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)
Liver, Adverse Event, Imaging of liver, Gallstones/gallbladder problems, Lesion
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C3842395 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,5])
Item
Biliary ductal lesions?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0005423 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,5])
Imaging of liver, Biliary tract structure, Lesion
Code List
Biliary ductal lesions?
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 ducts) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis Choledocholithiasis (gallstone in duct)  (8)
CL Item
Ductal filling defect(s), other than gallstone  (9)
CL Item
Ductal wall thickening or oedema  (10)
CL Item
Choledochal cyst (11)
CL Item
Ductal mass (12)
CL Item
Extrinsic mass compressing bile duct(s) (13)
CL Item
Other, specify (14)
Liver, Adverse Event, Imaging of liver, Biliary tract structure, Lesion
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0005423 (UMLS CUI [1,4])
C0221198 (UMLS CUI [1,5])
Item
Portal/Hepatic vein abnormalities?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0019155 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,5])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C2711860 (UMLS CUI [2,3])
C0032718 (UMLS CUI [2,4])
C1704258 (UMLS CUI [2,5])
Imaging of liver, Structure of hepatic vein, Abnormality; Imaging of liver, Portal vein structure, Abnormality
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Nonocclusive portal vein thrombosis  (4)
CL Item
Occlusive portal vein thrombosis - bland  (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant  (8)
CL Item
Involvement of the main portal vein  (9)
CL Item
Involvement of the right portal vein  (10)
CL Item
Involvement of the left portal vein  (11)
CL Item
Budd-Chiari syndrome (12)
CL Item
Other, specify (13)
Liver, Adverse Event, Imaging of liver, Structure of hepatic vein, Abnormality; Liver, Adverse Event, Imaging of liver, Portal vein structure, Abnormality
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2711860 (UMLS CUI [1,3])
C0019155 (UMLS CUI [1,4])
C1704258 (UMLS CUI [1,5])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C2711860 (UMLS CUI [2,3])
C0032718 (UMLS CUI [2,4])
C1704258 (UMLS CUI [2,5])
Item Group
Liver Biopsy
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0193388 (UMLS CUI-3)
Liver, Adverse Event, Biopsy of liver, Date in time
Item
Date of liver biopsy
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Liver, Adverse Event, Biopsy of liver, Specimen size
Item
Approximate size of liver biopsy
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1299482 (UMLS CUI [1,4])
Item
Biopsy size unit
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1299482 (UMLS CUI [1,4])
C1519795 (UMLS CUI [1,5])
Biopsy of liver, Specimen size, Unit of Measure
Code List
Biopsy size unit
CL Item
mm (1)
Item
Final Diagnosis
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1546485 (UMLS CUI [1,4])
Biopsy of liver, Diagnosis Type - Final
Code List
Final Diagnosis
CL Item
Normal (1)
CL Item
Acute hepatitis (2)
CL Item
Chronic hepatitis (3)
CL Item
Cholestatic hepatitis  (4)
CL Item
Drug-induced cholestasis  (5)
CL Item
Acute viral hepatitis (6)
CL Item
Chronic viral hepatitis  (7)
CL Item
Drug-induced hepatitis  (8)
CL Item
Autoimmune hepatitis  (9)
CL Item
Bridging necrosis  (10)
CL Item
Submassive hepatic necrosis  (11)
CL Item
Massive hepatic necrosis  (12)
CL Item
Steatosis - microvesicular  (13)
CL Item
Steatosis - macrovesicular  (14)
CL Item
Steatosis - mixed  (15)
CL Item
Non-alcoholic steatohepatitis  (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas  (18)
CL Item
Sarcoidosis Fibrosis (19)
CL Item
Cirrhosis (20)
CL Item
Primary biliary cirrhosis  (21)
CL Item
Primary sclerosing cholangitis  (22)
CL Item
Autoimmune overlap syndrome  (23)
CL Item
Hemochromatosis  (24)
CL Item
Alpha-1-antitrypsin 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)
Liver, Adverse Event, Biopsy of liver, Diagnosis Type - Final
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1546485 (UMLS CUI [1,4])
Item
Liver Architecture
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0935919 (UMLS CUI [1,4])
Biopsy of liver, Cellular structure aspects
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno-occlusive disease (9)
CL Item
Canalicular cholestasis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis (12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)  (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Focal coagulative necrosis (16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (17)
CL Item
Bridging hepatocellular necrosis (18)
CL Item
Massive or panlobular hepatocellular necrosis (19)
CL Item
Dysplasia (20)
CL Item
Neoplasia (21)
CL Item
Other, specify (22)
Liver, Adverse Event, Biopsy of liver, Cellular structure aspects
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0935919 (UMLS CUI [1,4])
Item
Description of Liver Cells or Hepatocytes
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C0678257 (UMLS CUI [1,5])
Biopsy of liver, Hepatocyte, Description
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic  (3)
CL Item
Pseudoxanthomatous  (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other, specify (6)
Liver, Adverse Event, Biopsy of liver, Hepatocyte, Description
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C0678257 (UMLS CUI [1,5])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C0042219 (UMLS CUI [1,5])
C1512693 (UMLS CUI [1,6])
Biopsy of liver, Hepatocyte, Vacuole, Inclusion
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions  (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions  (5)
CL Item
Alpha-1-antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein-positive cytoplasmin granules (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light)  (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other, specify (15)
Liver, Adverse Event, Biopsy of liver, Hepatocyte, Vacuole, Inclusion
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C0042219 (UMLS CUI [1,5])
C1512693 (UMLS CUI [1,6])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C1849376 (UMLS CUI [1,5])
Biopsy of liver, Hepatocyte, Abnormal nuclear morphology
Code List
Hepatocyte or Liver Cell Nuclear Abnormalities
CL Item
None (1)
CL Item
Hepatocellular mitosis (2)
CL Item
Binucleated or multinucleated hepatocytes  (3)
CL Item
CMV inclusion bodies (4)
CL Item
HSV inclusions (5)
CL Item
Varicella inclusions (6)
CL Item
Other, specify (7)
Liver, Adverse Event, Biopsy of liver, Hepatocyte, Abnormal nuclear morphology
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0227525 (UMLS CUI [1,4])
C1849376 (UMLS CUI [1,5])
Item
Liver or Lobular Infiltrates
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0205417 (UMLS CUI [1,4])
Biopsy of liver, Infiltrate
Code List
Liver or Lobular Infiltrates
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer cells  (6)
CL Item
Granulomas (7)
CL Item
Other, specify (8)
Liver, Adverse Event, Biopsy of liver, Infiltrate
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0205417 (UMLS CUI [1,4])
Item
Portal Tract Inflammation
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C3854488 (UMLS CUI [1,4])
Biopsy of liver, Infiltrate
Code List
Portal Tract Inflammation
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/or follicles  (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other, specify (7)
Liver, Adverse Event, Biopsy of liver, Portal Tract Inflammation
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C3854488 (UMLS CUI [1,4])
Item
Bile Ducts
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
Biopsy of liver, Portal Tract Inflammation
Code List
Bile Ducts
CL Item
Normal (1)
CL Item
Proliferation of bile ducts (bile ductular reaction)  (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts  (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other, specify (6)
Liver, Adverse Event, Biopsy of liver, Bile duct structure
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0005400 (UMLS CUI [1,4])
Item
Portal Veins
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,4])
Biopsy of liver, Portal vein structure
Code List
Portal Veins
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein  (3)
CL Item
Neoplastic invasion of portal vein  (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
Other, specify (6)
Liver, Adverse Event, Biopsy of liver, Portal vein structure
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0032718 (UMLS CUI [1,4])
Item
Liver Infections
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1112211 (UMLS CUI [1,4])
Biopsy of liver, Hepatic infection
Code List
Liver Infections
CL Item
Normal (1)
CL Item
Leishmaniasis donovani  (2)
CL Item
Plasmodium falciparum  (3)
CL Item
Toxoplasmosis  (4)
CL Item
Cryptococcus neoformans  (5)
CL Item
Histoplasma capsulatum  (6)
CL Item
Mycobacterium tuberculois  (7)
CL Item
Other mycobacterial species (8)
CL Item
Other, specify (9)
Liver, Adverse Event, Biopsy of liver, Hepatic infection
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C1112211 (UMLS CUI [1,4])
Item
Parasites or Ova
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0030498 (UMLS CUI [1,4])
C1267673 (UMLS CUI [1,5])
Biopsy of liver, Parasite, Ovum of parasite
Code List
Parasites or Ova
CL Item
None (1)
CL Item
Schistosome and/or ova (2)
CL Item
Ascaris and/or ova (3)
CL Item
Toxocara and/or ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic capillariasis worms and/or ova (6)
CL Item
Other, specify (7)
Liver, Adverse Event, Biopsy of liver, Parasite, Ovum of parasite
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0030498 (UMLS CUI [1,4])
C1267673 (UMLS CUI [1,5])
Item
Histologic Staining or Additional Studies Obtained
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,4])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
Biopsy of liver, Staining method; Biopsy of liver, Study Subject Participation Status
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 O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain  (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Liver, Adverse Event, Biopsy of liver, Staining method; Liver, Adverse Event, Biopsy of liver, Study Subject Participation Status
Item
Other, specify
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
C0487602 (UMLS CUI [1,4])
C0023884 (UMLS CUI [2,1])
C0877248 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
C2348568 (UMLS CUI [2,4])
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