ID

35253

Description

Study ID: 102970 Clinical Study ID: 102970 Study Title: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01017952 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: GW642444 Inhalation Powder; FF/GW642444 Inhalation Powder Trade Name: Fluticasone Furoate;Fluticasone Propionate;Fluticasone Propionate/Salmeterol;Salmeterol;Vilanterol Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

  1. 2/25/19 2/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 25, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Effect of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on Annual Rate of Exacerbations in Subjects with COPD; 102970

LE Details

  1. StudyEvent: ODM
    1. LE Details
Administrative Data
Description

Administrative Data

Site
Description

Study Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Clinical trial participant

Data type

text

Alias
UMLS CUI [1]
C1997894
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Description

Date of Visit/Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of visit/assessment
Description

Date of visit, Assessment Date

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Pharmacokinetics
Description

Pharmacokinetics

Alias
UMLS CUI-1
C0031328
Was a pharmacokinetic blood sample obtained?
Description

Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure

Data type

boolean

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

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

Data type

datetime

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

Pharmacokinetic aspects, Experimental drug,Date last dose, Time last dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1762893
UMLS CUI [1,4]
C0946444
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Is this liver event a serious adverse event?
Description

Liver, Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1519255
Notification Sent - Last Email Sent to Medical Monitor
Description

Liver, Adverse Event, Medical Monitor, Email, Last, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1708968
UMLS CUI [1,4]
C0013849
UMLS CUI [1,5]
C1517741
UMLS CUI [1,6]
C0011008
UMLS CUI [1,7]
C0040223
Notification Sent - Initial Email Sent to Medical Monitor
Description

Liver, Adverse Event, Medical Monitor, Email, First, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1708968
UMLS CUI [1,4]
C0013849
UMLS CUI [1,5]
C0205435
UMLS CUI [1,6]
C0011008
UMLS CUI [1,7]
C0040223
Notification Sent - Last Email Sent to Medical Monitor
Description

Liver, Adverse Event, Clinical Trial Safety Documentation, Email, Last, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3899555
UMLS CUI [1,4]
C0013849
UMLS CUI [1,5]
C1517741
UMLS CUI [1,6]
C0011008
UMLS CUI [1,7]
C0040223
Notification Sent - Initial Email Sent to GCSP
Description

Liver, Adverse Event, Clinical Trial Safety Documentation, Email, First, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C3899555
UMLS CUI [1,4]
C0013849
UMLS CUI [1,5]
C0205435
UMLS CUI [1,6]
C0011008
UMLS CUI [1,7]
C0040223
Notification Sent - Changed to Non Serious on
Description

Liver, Adverse Event, Non-Serious Adverse Event, Date in time, Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1518404
UMLS CUI [1,4]
C0011008
UMLS CUI [1,5]
C0040223
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/monitoring criteria? Check all that apply
Description

Liver, Adverse Event, Laboratory test finding, Abnormality

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C1704258
Is the subject age 55 or older?
Description

Age

Data type

boolean

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

Pregnancy

Data type

text

Alias
UMLS CUI [1]
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

Imaging of liver

Data type

boolean

Alias
UMLS CUI [1]
C2711860
If Yes, were the results normal?
Description

Imaging of liver, Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0205307
Were any liver biopsies performed?
Description

Biopsy of liver

Data type

boolean

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

Herbal medicine (product); Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use

Data type

boolean

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

Fasting, Change in diet

Data type

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C3671772
When did the liver event occur?
Description

Liver, Adverse Event, Occurrence

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
Start Date Investigational Product
Description

Liver, Adverse Event, Experimental drug, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0304229
UMLS CUI [1,4]
C0808070
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
Medical Conditions
Description

Medical Conditions

Alias
UMLS CUI-1
C0012634
Acute Viral Hepatitis A
Description

Acute type A viral hepatitis

Data type

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Hepatitis B, Chronic

Data type

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Hepatitis C, Chronic

Data type

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

text

Alias
UMLS CUI [1]
C0276252
Epstein Barr Virus Infectious Mononucleosis
Description

Infectious Mononucleosis; Epstein-Barr Virus

Data type

text

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Description

Herpes Simplex Hepatitis

Data type

text

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Description

Alcoholic Liver Diseases

Data type

text

Alias
UMLS CUI [1]
C0023896
Non-alcoholic Steatohepatitis
Description

Nonalcoholic Steatohepatitis

Data type

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Description

Fatty Liver

Data type

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Description

Liver Cirrhosis

Data type

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Hepatitis, Autoimmune

Data type

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Description

Gall Bladder Diseases

Data type

text

Alias
UMLS CUI [1]
C0016977
Drug related liver disease
Description

Liver diseases; Drug-related disorder

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other Liver Disease Conditions - Specific Condition
Description

Liver diseases; Other

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
Other Liver Disease Conditions - Status
Description

Liver diseases; Other, Status

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Drug Allergies
Description

Pharmaceutical Preparations; Hypersensitivity

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0020517
Rheumatoid Arthritis
Description

Rheumatoid Arthritis

Data type

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Diseases

Data type

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Diseases

Data type

text

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus Erythematosus

Data type

text

Alias
UMLS CUI [1]
C0409974
Sjogren's Syndrome
Description

Sjogren's Syndrome

Data type

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

text

Alias
UMLS CUI [1]
C0042900
Alcohol Intake at Start of Liver Event
Description

Alcohol Intake at Start of Liver Event

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C0023884
UMLS CUI-3
C0877248
UMLS CUI-4
C0332162
Does the subject consume alcohol?
Description

Alcohol consumption

Data type

boolean

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

Alcohol consumption; alcohol units/week

Data type

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Liver Imaging
Description

Liver Imaging

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

Imaging of liver, Date in time

Data type

date

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

Imaging of liver, Imaging modality

Data type

text

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

Imaging of liver, Adequate

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0332306
Indicate the liver size
Description

Imaging of liver, Liver size

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0426688
Indicate the liver texture
Description

Imaging of liver, Texture Perceiption

Data type

text

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

Imaging of liver, Fatty Liver

Data type

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0015695
Ascites present
Description

Imaging of liver, Ascites

Data type

text

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

Imaging of liver, Lesion of liver, Focal

Data type

text

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

Imaging of liver, Gallstones/Gallbladder problems, Lesions

Data type

text

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

Imaging of liver, Biliary duct structure, lesions

Data type

text

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

Imaging of liver, Portal vein structure, Structure of hepatic vein, Abnormality

Data type

text

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

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Biopsy of liver, Date in time

Data type

date

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

Biopsy of liver, Specimen size

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1299482
mmHg
Final Diagnosis
Description

Biopsy of liver, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011900
Liver Architecture
Description

Biopsy of liver, Cellular structure aspects

Data type

text

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

Biopsy of liver, Hepatocyte

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0227525
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Biopsy of liver, Hepatocyte, Inclusion, Vacuoles

Data type

text

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

Biopsy of Liver, Hepatocyte, Abnormal nuclear morphology

Data type

text

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

Biopsy of liver, Infiltrates

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1400896
Portal Tract Inflammation
Description

Biopsy of liver, Portal Tract Inflammation

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C3854488
Bile Ducts
Description

Biopsy of liver, Bile Duct structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0005400
Portal Veins
Description

Biopsy of liver, Portal Vein structure

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0032718
Liver Infections
Description

Biopsy of liver, Hepatic Infection

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1112211
Parasites or Ova
Description

Biopsy of liver, Parasite, Ovum of parasite

Data type

text

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

Biopsy of liver, Staining method

Data type

text

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0487602

Similar models

LE Details

  1. StudyEvent: ODM
    1. LE Details
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Study Site
Item
Site
text
C2825164 (UMLS CUI [1])
Clinical trial participant
Item
Subject
text
C1997894 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of visit, Assessment Date
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Pharmacokinetics
C0031328 (UMLS CUI-1)
Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Pharmacokinetic aspects, Collection of blood specimen for laboratory procedure, Date in time, Time
Item
Yes, date and time sample taken
datetime
C0031328 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Pharmacokinetic aspects, Experimental drug,Date last dose, Time last dose
Item
If Yes, date and time of last investigational product dose prior to PK sample
datetime
C0031328 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,4])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver, Serious Adverse Event
Item
Is this liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Liver, Adverse Event, Medical Monitor, Email, Last, Date in time, Time
Item
Notification Sent - Last Email Sent to Medical Monitor
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
Liver, Adverse Event, Medical Monitor, Email, First, Date in time, Time
Item
Notification Sent - Initial Email Sent to Medical Monitor
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
Liver, Adverse Event, Clinical Trial Safety Documentation, Email, Last, Date in time, Time
Item
Notification Sent - Last Email Sent to Medical Monitor
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C1517741 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
Liver, Adverse Event, Clinical Trial Safety Documentation, Email, First, Date in time, Time
Item
Notification Sent - Initial Email Sent to GCSP
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3899555 (UMLS CUI [1,3])
C0013849 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,6])
C0040223 (UMLS CUI [1,7])
Liver, Adverse Event, Non-Serious Adverse Event, Date in time, Time
Item
Notification Sent - Changed to Non Serious on
datetime
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0040223 (UMLS CUI [1,5])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/monitoring criteria? Check all that apply
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/monitoring criteria? Check all that apply
CL Item
ALT (alanine aminotransferase)  (1)
CL Item
AST (aspartate aminotransferase)  (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5` nucleotidase  (5)
CL Item
Gammaglutamyltranspeptidase  (6)
CL Item
Other (7)
Age
Item
Is the subject age 55 or older?
boolean
C0001779 (UMLS CUI [1])
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Code List
If female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Imaging of liver
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
C2711860 (UMLS CUI [1])
Imaging of liver, Normal
Item
If Yes, were the results normal?
boolean
C2711860 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Biopsy of liver
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbal medicine (product); Complementary Medicine; Alternative Medicine; Dietary Supplements; Illicit medication use
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1,1])
C1148474 (UMLS CUI [1,2])
C0002346 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
C0281875 (UMLS CUI [1,5])
Fasting, Change in diet
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1,1])
C3671772 (UMLS CUI [1,2])
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
Code List
When did the liver event occur?
CL Item
During the treatment period: If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. (1)
CL Item
After the treatment period: 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. (2)
Liver, Adverse Event, Experimental drug, Start Date
Item
Start Date Investigational Product
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,4])
Liver, Adverse Event, Experimental drug, End Date
Item
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 Group
Medical Conditions
C0012634 (UMLS CUI-1)
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
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
C0524909 (UMLS CUI [1])
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
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
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
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
C1963747 (UMLS CUI [1])
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Liver diseases; Other
Item
Other Liver Disease Conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
Other Liver Disease Conditions - Status
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Code List
Other Liver Disease Conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item
Drug Allergies
text
C0013227 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Code List
Drug Allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Lupus
text
C0409974 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Sjogren's Syndrome
text
C1527336 (UMLS CUI [1])
Code List
Sjogren's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol Intake at Start of Liver Event
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332162 (UMLS CUI-4)
Alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Alcohol consumption; alcohol units/week
Item
Yes, record the average number of units of alcohol consumed per week
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Liver Imaging
C2711860 (UMLS CUI-1)
Imaging of liver, Date in time
Item
Date of hepatic or liver imaging test
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
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)
Item
Are images technically adequate?
text
C2711860 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
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)
Item
Indicate the liver size
text
C2711860 (UMLS CUI [1,1])
C0426688 (UMLS CUI [1,2])
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)
Item
Indicate the liver texture
text
C2711860 (UMLS CUI [1,1])
C0679033 (UMLS CUI [1,2])
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)
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C2711860 (UMLS CUI [1,1])
C0015695 (UMLS CUI [1,2])
Code List
Grade the diffuse and/or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration  (1)
CL Item
Mild (<=25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>=75%) (4)
CL Item
Other, specify (5)
Item
Ascites present
text
C2711860 (UMLS CUI [1,1])
C0003962 (UMLS CUI [1,2])
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)
Item
Are Focal Hepatic Lesions characterisable?
text
C2711860 (UMLS CUI [1,1])
C0577053 (UMLS CUI [1,2])
C0205234 (UMLS CUI [1,3])
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)
Item
Gallstones or gallbladder lesions?
text
C2711860 (UMLS CUI [1,1])
C3842395 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
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)
Item
Biliary ductal lesions?
text
C2711860 (UMLS CUI [1,1])
C0005423 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
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  (8)
CL Item
Choledocholithiasis (gallstone in duct)  (9)
CL Item
Ductal filling defect(s), other than gallstone  (10)
CL Item
Ductal wall thickening or oedema  (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other, specify (15)
Item
Portal/Hepatic vein abnormalities?
text
C2711860 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
C0019155 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
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)
Item Group
Liver Biopsy
C0193388 (UMLS CUI-1)
Biopsy of liver, Date in time
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Biopsy of liver, Specimen size
Item
Approximate size of liver biopsy
integer
C0193388 (UMLS CUI [1,1])
C1299482 (UMLS CUI [1,2])
Item
Final Diagnosis
text
C0193388 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
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  (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis  (22)
CL Item
Primary sclerosing cholangitis  (23)
CL Item
Autoimmune overlap syndrome  (24)
CL Item
Hemochromatosis  (25)
CL Item
Alpha-1-antitrypsin deficiency  (26)
CL Item
Wilson's disease  (27)
CL Item
Veno-occlusive disease  (28)
CL Item
Budd-Chiari syndrome  (29)
CL Item
Neoplasia (30)
CL Item
Other, specify (31)
Item
Liver Architecture
text
C0193388 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
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
22Other, specify (22Other, specify)
Item
Description of Liver Cells or Hepatocytes
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
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)
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
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)
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0193388 (UMLS CUI [1,1])
C0227525 (UMLS CUI [1,2])
C1849376 (UMLS CUI [1,3])
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)
Item
Liver or Lobular Infiltrates
text
C0193388 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
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 Granulomas (6)
CL Item
Other, specify (7)
Item
Portal Tract Inflammation
text
C0193388 (UMLS CUI [1,1])
C3854488 (UMLS CUI [1,2])
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)
Item
Bile Ducts
text
C0193388 (UMLS CUI [1,1])
C0005400 (UMLS CUI [1,2])
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)
Item
Portal Veins
text
C0193388 (UMLS CUI [1,1])
C0032718 (UMLS CUI [1,2])
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)
Item
Liver Infections
text
C0193388 (UMLS CUI [1,1])
C1112211 (UMLS CUI [1,2])
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)
Item
Parasites or Ova
text
C0193388 (UMLS CUI [1,1])
C0030498 (UMLS CUI [1,2])
C1267673 (UMLS CUI [1,3])
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)
Item
Histologic Staining or Additional Studies Obtained
text
C0193388 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E)  (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase  (5)
CL Item
Oil red 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)

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