ID

41886

Description

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document documents any liver events that might happen during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Keywords

Versions (1)
  1. 2/9/21 2/9/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 9, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

English

Liver Events Assessment

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
subject ID
Description

subject ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Liver Events Assessment
Description

Liver Events Assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
liver monitoring criteria (subject has met protocol defined liver event monitoring criteria)
Description

This and the following two items are the options for type of liver chemistry event, only one can be chosen. Note: If a subject has been monitored for {insert protocol specific time} and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. if type of liver chemistry event is Liver Monitoring, obtain tests as per protocol.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0030695
Liver Event Interruption Criteria (subject has met protocol defined liver event interruption criteria)
Description

Note: If a subject has been monitored for {insert protocol specific time} and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. if type of liver chemistry event is Liver Event (Interruption), interrupt investigational product, complete date interrupted on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE:If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Obtain tests as per protocol * Obtain blood samples for pharmacokinetic (PK) analysis within 3 DAYS of last dose * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C1512900
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for 4 WEEKS and continues to meet liver chemistry event criteria)
Description

Note: If a subject has been monitored for {insert protocol specific time} and continues to meet liver chemistry monitoring criteria, subject must be identified as a liver event. if type of liver chemistry event is Liver Event (Stopping), stop investigational product, complete date stopped on Investigational Product Form and contact GSK within 24 hours of occurrence of liver event by phone or fax. NOTE:If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. * Obtain tests as per protocol * Obtain blood samples for pharmacokinetic (PK) analysis within 3 DAYS of last dose * Complete Liver Event Forms (completed Liver Event Forms do not need to be supplied to GSK within 24 hours)

Data type

boolean

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C2746065
Liver Events
Description

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Did the ALT result reach or exceed protocol-defined investigational product stopping criteria?
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Did the total bilirubin result reach or exceed protocol-defined investigational product stopping criteria?
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Is the subject age 55 or older?
Description

age

Data type

boolean

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

if yes, ensure pregnancy notification form has been completed

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

diagnostic imaging of the liver or hepatobiliary system

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
if yes, were the results normal?
Description

if no, record the details on the Non-Serious-Adverse Events form or Serious Adverse Event form

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205307
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [2,3]
C0205307
were any liver biopsies performed?
Description

if yes, complete liver biopsy form

Data type

boolean

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

if yes, document on the appropriate Concomitant Medication form

Data type

boolean

Alias
UMLS CUI [1]
C2240391
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Description

subject recently fasted or underwent significant dietary change

Data type

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0015663
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C3671772
UMLS CUI [2,3]
C0750502
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
When did the liver event occur?
Description

liver event occurance time

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0011008
liver event, start date
Description

liver event, start date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0808070
liver event, end date
Description

liver event, end date

Data type

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0806020
Local Laboratory Lab Tests Exclusive to Liver Events (Liver Lab)
Description

Local Laboratory Lab Tests Exclusive to Liver Events (Liver Lab)

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0205276
UMLS CUI-3
C0023884
UMLS CUI-4
C0877248
Laboratory ID [read only]
Description

Laboratory ID

Data type

text

Alias
UMLS CUI [1]
C2986056
Laboratory name and adress
Description

Laboratory name and adress

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0027365
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C1301826
Laboratory name
Description

Laboratory name and adress

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0027365
Laboratory adress
Description

Laboratory name and adress

Data type

text

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C1301826
date and time sample taken
Description

date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0200345
UMLS CUI [2,1]
C0040223
UMLS CUI [2,2]
C0200345
creatine kinase
Description

result type: creatine kinase

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0010287
creatine kinase numeric result, please specify
Description

creatine kinase numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C2347373
creatine kinase character result, please specify
Description

creatine kinase character result

Data type

text

Alias
UMLS CUI [1,1]
C0201973
UMLS CUI [1,2]
C2350015
lactate dehydrogenase
Description

result type: lactate dehydrogenase

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0202113
lactate dehydrogenase numeric result, please specify
Description

lactate dehydrogenase numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C2347373
lactate dehydrogenase character result, please specify
Description

lactate dehydrogenase character result

Data type

text

Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C2350015
Actin (Smooth Muscle) IgG Antibody
Description

result type: Actin (Smooth Muscle) IgG Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1532316
Actin (Smooth Muscle) IgG Antibody numeric result, please specify
Description

Actin (Smooth Muscle) IgG Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C1532316
UMLS CUI [1,2]
C2347373
Actin (Smooth Muscle) IgG Antibody character result, please specify
Description

Actin (Smooth Muscle) IgG Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C1532316
UMLS CUI [1,2]
C2350015
Anti-Nuclear Antibody-Screen
Description

result type: Anti-Nuclear Antibody-Screen

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
UMLS CUI [1,4]
C0220908
Anti-Nuclear Antibody-Screen numeric result, please specify
Description

Anti-Nuclear Antibody-Screen numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C2347373
Anti-Nuclear Antibody-Screen character result, please specify
Description

Anti-Nuclear Antibody-Screen character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C2350015
Anti-Nuclear Antibody
Description

result type: Anti-Nuclear Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
Anti-Nuclear Antibody numeric result, please specify
Description

Anti-Nuclear Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2347373
Anti-Nuclear Antibody character result, please specify
Description

Anti-Nuclear Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2350015
Anti-Nuclear Antibody 2
Description

result type: Anti-Nuclear Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
Anti-Nuclear Antibody 2 numeric result, please specify
Description

Anti-Nuclear Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2347373
Anti-Nuclear Antibody 2 character result, please specify
Description

Anti-Nuclear Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2350015
Anti-Nuclear Antibody 3
Description

result type: Anti-Nuclear Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
Anti-Nuclear Antibody 3 numeric result, please specify
Description

Anti-Nuclear Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2347373
Anti-Nuclear Antibody 3 character result, please specify
Description

Anti-Nuclear Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2350015
Anti-Nuclear Antibody 4
Description

result type: Anti-Nuclear Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
Anti-Nuclear Antibody 4 numeric result, please specify
Description

Anti-Nuclear Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2347373
Anti-Nuclear Antibody 4 character result, please specify
Description

Anti-Nuclear Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C2350015
Anti-Nuclear Antibody Pattern
Description

result type: Anti-Nuclear Antibody Pattern

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
UMLS CUI [1,4]
C0449774
Anti-Nuclear Antibody Pattern numeric result, please specify
Description

Anti-Nuclear Antibody Pattern numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2347373
Anti-Nuclear Antibody Pattern character result, please specify
Description

Anti-Nuclear Antibody Pattern character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2350015
Anti-Nuclear Antibody Pattern 2
Description

result type: Anti-Nuclear Antibody Pattern

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
UMLS CUI [1,4]
C0449774
Anti-Nuclear Antibody Pattern 2 numeric result, please specify
Description

Anti-Nuclear Antibody Pattern numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2347373
Anti-Nuclear Antibody Pattern 2 character result, please specify
Description

Anti-Nuclear Antibody Pattern character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2350015
Anti-Nuclear Antibody Pattern 3
Description

result type: Anti-Nuclear Antibody Pattern

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
UMLS CUI [1,4]
C0449774
Anti-Nuclear Antibody Pattern 3 numeric result, please specify
Description

Anti-Nuclear Antibody Pattern numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2347373
Anti-Nuclear Antibody Pattern 3 character result, please specify
Description

Anti-Nuclear Antibody Pattern character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2350015
Anti-Nuclear Antibody Pattern 4
Description

result type: Anti-Nuclear Antibody Pattern

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0587178
UMLS CUI [1,4]
C0449774
Anti-Nuclear Antibody Pattern 4 numeric result, please specify
Description

Anti-Nuclear Antibody Pattern numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2347373
Anti-Nuclear Antibody Pattern 4 character result, please specify
Description

Anti-Nuclear Antibody Pattern character result

Data type

text

Alias
UMLS CUI [1,1]
C0587178
UMLS CUI [1,2]
C0449774
UMLS CUI [1,3]
C2350015
Cytomegalovirus IgM Antibody
Description

result type: Cytomegalovirus IgM Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C3272889
Cytomegalovirus IgM Antibody numeric result, please specify
Description

Cytomegalovirus IgM Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C3272889
UMLS CUI [1,2]
C2347373
Cytomegalovirus IgM Antibody character result, please specify
Description

Cytomegalovirus IgM Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C3272889
UMLS CUI [1,2]
C2350015
Epstein-Barr Viral Capsid Antigen IgM Antibody
Description

result type: Epstein-Barr Viral Capsid Antigen IgM Antibody

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C3272892
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result, please specify
Description

Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result

Data type

text

Alias
UMLS CUI [1,1]
C3272892
UMLS CUI [1,2]
C2347373
Epstein-Barr Viral Capsid Antigen IgM Antibody character result, please specify
Description

Epstein-Barr Viral Capsid Antigen IgM Antibody character result

Data type

text

Alias
UMLS CUI [1,1]
C3272892
UMLS CUI [1,2]
C2350015
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
Description

result type: Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C3272892
UMLS CUI [1,4]
C0871362
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result, please specify
Description

Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result

Data type

text

Alias
UMLS CUI [1,1]
C3272892
UMLS CUI [1,2]
C0871362
UMLS CUI [1,3]
C2347373
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result, please specify
Description

Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result

Data type

text

Alias
UMLS CUI [1,1]
C3272892
UMLS CUI [1,2]
C0871362
UMLS CUI [1,3]
C2350015
Hepatitis A IgM Antibody Total (Qualitative)
Description

result type: Hepatitis A IgM Antibody Total (Qualitative)

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0373852
UMLS CUI [1,4]
C0205556
Hepatitis A IgM Antibody Total (Qualitative) numeric result, please specify
Description

Hepatitis A IgM Antibody Total (Qualitative) numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0373852
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2347373
Hepatitis A IgM Antibody Total (Qualitative) character result, please specify
Description

Hepatitis A IgM Antibody Total (Qualitative) character result

Data type

text

Alias
UMLS CUI [1,1]
C0373852
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2350015
Hepatitis B Core IgM Antibody (Qualitative)
Description

result type: Hepatitis B Core IgM Antibody (Qualitative)

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0201480
UMLS CUI [1,4]
C0202084
UMLS CUI [1,5]
C0205556
Hepatitis B Core IgM Antibody (Qualitative) numeric result, please specify
Description

Hepatitis B Core IgM Antibody (Qualitative) numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0201480
UMLS CUI [1,2]
C0202084
UMLS CUI [1,3]
C0205556
UMLS CUI [1,4]
C2347373
Hepatitis B Core IgM Antibody (Qualitative) character result, please specify
Description

Hepatitis B Core IgM Antibody (Qualitative) character result

Data type

text

Alias
UMLS CUI [1,1]
C0201480
UMLS CUI [1,2]
C0202084
UMLS CUI [1,3]
C0205556
UMLS CUI [1,4]
C2350015
Hepatitis B Surface Antigen (Qualitative)
Description

result type: Hepatitis B Surface Antigen (Qualitative)

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0019168
UMLS CUI [1,4]
C0205556
Hepatitis B Surface Antigen (Qualitative) numeric result, please specify
Description

Hepatitis B Surface Antigen (Qualitative) numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2347373
Hepatitis B Surface Antigen (Qualitative) character result, please specify
Description

Hepatitis B Surface Antigen (Qualitative) character result

Data type

text

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2350015
Hepatitis E IgM Antibody Total (Qualitative)
Description

result type: Hepatitis E IgM Antibody Total (Qualitative)

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C3272944
UMLS CUI [1,4]
C0205556
Hepatitis E IgM Antibody Total (Qualitative) numeric result, please specify
Description

Hepatitis E IgM Antibody Total (Qualitative) numeric result

Data type

text

Alias
UMLS CUI [1,1]
C3272944
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2347373
Hepatitis E IgM Antibody Total (Qualitative) character result, please specify
Description

Hepatitis E IgM Antibody Total (Qualitative) character result

Data type

text

Alias
UMLS CUI [1,1]
C3272944
UMLS CUI [1,2]
C0205556
UMLS CUI [1,3]
C2350015
Liver Kidney Microsomal Antibody IgG
Description

result type: Liver Kidney Microsomal Antibody IgG

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C0051982
UMLS CUI [1,4]
C0020852
Liver Kidney Microsomal Antibody IgG numeric result, please specify
Description

Liver Kidney Microsomal Antibody IgG numeric result

Data type

text

Alias
UMLS CUI [1,1]
C0051982
UMLS CUI [1,2]
C0020852
UMLS CUI [1,3]
C2347373
Liver Kidney Microsomal Antibody IgG character result, please specify
Description

Liver Kidney Microsomal Antibody IgG character result

Data type

text

Alias
UMLS CUI [1,1]
C0051982
UMLS CUI [1,2]
C0020852
UMLS CUI [1,3]
C2350015
Hepatitis C RNA PCR
Description

result type: Hepatitis C RNA PCR

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1272251
UMLS CUI [1,4]
C0032520
Hepatitis C RNA PCR numeric result, please specify
Description

Hepatitis C RNA PCR numeric result

Data type

text

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C2347373
UMLS CUI [1,3]
C0032520
Hepatitis C RNA PCR character result, please specify
Description

Hepatitis C RNA PCR character result

Data type

text

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C0032520
Hepatitis C RNA PCR Log
Description

result type: Hepatitis C RNA PCR Log

Data type

text

Alias
UMLS CUI [1,1]
C1274040
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1272251
UMLS CUI [1,4]
C3873230
Hepatitis C RNA PCR Log numeric result, please specify
Description

Hepatitis C RNA PCR Log numeric result

Data type

text

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C2347373
UMLS CUI [1,3]
C3873230
Hepatitis C RNA PCR Log character result, please specify
Description

Hepatitis C RNA PCR Log character result

Data type

text

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C2350015
UMLS CUI [1,3]
C3873230
Pharmacokinetics (Liver PK)
Description

Pharmacokinetics (Liver PK)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0023884
Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK blood sample must be obtained within 24 hours of last dose (or 3x the investigational product half-life or t1/2; protocol specified longer value to be inserted).

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
if yes, please specify date and time sample taken
Description

pharmacokinetic blood sample date and time

Data type

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1264639
if yes, please specify date and time of last investigational product dose prior to PK sample
Description

date and time of last investigational product dose

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0946444
if yes, please specify sample identifier / sample number
Description

sample identifier / sample number, pharmacokinetic aspects

Data type

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0031328
Medical Conditions at Onset of Liver Event (LIVER MEDHX)
Description

Medical Conditions at Onset of Liver Event (LIVER MEDHX)

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
Acute Viral Hepatitis A
Description

Acute Viral Hepatitis A

Data type

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Chronic Hepatitis B

Data type

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Chronic Hepatitis C

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

Epstein Barr Virus Infectious Mononucleosis

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 Disease

Data type

text

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

Non-alcoholic 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

Hepatic Cirrhosis

Data type

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Description

Gallbladder disease

Data type

text

Alias
UMLS CUI [1]
C0016977
Liver metastases
Description

Liver metastases

Data type

text

Alias
UMLS CUI [1]
C0494165
Hepatitis E IgM Antibody
Description

Hepatitis E IgM Antibody

Data type

text

Alias
UMLS CUI [1]
C3272944
Drug related liver disease
Description

Drug related liver disease

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other Liver Disease Conditions at Onset of Liver Event
Description

Other Liver Disease Conditions at Onset of Liver Event

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
UMLS CUI-3
C0332162
UMLS CUI-4
C0877248
UMLS CUI-5
C0023884
Sequence Number [hidden]
Description

Liver disease, Sequence Number [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2348184
Specific Condition
Description

Liver disease, Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C2348235
Modified Term [hidden]
Description

Liver disease, Modified Term [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C2826923
UMLS CUI [1,2]
C0023895
MedDRA Synonym [hidden]
Description

Liver disease, MedDRA Synonym [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C1140263
UMLS CUI [1,2]
C0871468
UMLS CUI [1,3]
C0023895
MedDRA lower level term code [hidden]
Description

Liver disease, MedDRA lower level term code [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C3898442
UMLS CUI [1,2]
C0023895
Failed coding [hidden]
Description

Liver disease, Failed coding [hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C0023895
Status
Description

Liver disease, Status

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0449438
Other Medical Conditions at Onset of Liver Event
Description

Other Medical Conditions at Onset of Liver Event

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
Drug Allergies
Description

Drug Allergies

Data type

integer

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

Rheumatoid Arthritis

Data type

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Disease

Data type

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus

Data type

integer

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

Sjogren's Syndrome

Data type

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

integer

Alias
UMLS CUI [1]
C0042900
Alcohol Intake at Onset of Liver Event (Liver Alcohol)
Description

Alcohol Intake at Onset of Liver Event (Liver Alcohol)

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

alcohol consumption

Data type

boolean

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

alcohol units per week

Data type

integer

Measurement units
  • alcohol units/week
Alias
UMLS CUI [1]
C0560579
alcohol units/week
substance use type
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
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Similar models

Liver Events Assessment

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject ID
Item
subject ID
text
C2348585 (UMLS CUI [1])
Item Group
Liver Events Assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Specify type of liver chemistry event: type of liver chemistry event, monitoring
Item
liver monitoring criteria (subject has met protocol defined liver event monitoring criteria)
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0030695 (UMLS CUI [1,4])
type of liver chemistry event, interruption
Item
Liver Event Interruption Criteria (subject has met protocol defined liver event interruption criteria)
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
type of liver chemistry event, stopping
Item
Liver Event Stopping Criteria (subject has met protocol defined liver event stopping criteria or has been monitored for 4 WEEKS and continues to meet liver chemistry event criteria)
boolean
C0008000 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
ALT (alanine aminotransferase) fulfilling investigational product stopping criteria
Item
Did the ALT result reach or exceed protocol-defined investigational product stopping criteria?
boolean
C0201836 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Total bilirubin fulfilling investigational product stopping criteria
Item
Did the total bilirubin result reach or exceed protocol-defined investigational product stopping criteria?
boolean
C0201913 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
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])
female, pregnant
Code List
if female, is the subject pregnant?
CL Item
Yes (1)
CL Item
No  (2)
CL Item
Not Applicable (3)
diagnostic imaging of the liver or hepatobiliary system
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
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
diagnostic imaging of the liver or hepatobiliary system normal
Item
if yes, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
liver biopsies
Item
were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2240391 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
subject recently fasted or underwent significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0332185 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C3671772 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
liver event occurance time
Code List
When did the liver event occur?
CL Item
during the treatment period  (1)
CL Item
after the treatment period (2)
liver event, start date
Item
liver event, start date
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
liver event, end date
Item
liver event, end date
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item Group
Local Laboratory Lab Tests Exclusive to Liver Events (Liver Lab)
C0022885 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
Laboratory ID
Item
Laboratory ID [read only]
text
C2986056 (UMLS CUI [1])
Item
Laboratory name and adress
text
C0022877 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C1301826 (UMLS CUI [2,2])
Laboratory name and adress
Code List
Laboratory name and adress
CL Item
results from the same lab as in the previous visit (1)
CL Item
please provide laboratory name and adress below (2)
Laboratory name and adress
Item
Laboratory name
text
C0022877 (UMLS CUI [1,1])
C0027365 (UMLS CUI [1,2])
Laboratory name and adress
Item
Laboratory adress
text
C0022877 (UMLS CUI [1,1])
C1301826 (UMLS CUI [1,2])
date and time sample taken
Item
date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
Item
creatine kinase
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0010287 (UMLS CUI [1,3])
creatine kinase
Code List
creatine kinase
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
creatine kinase numeric result
Item
creatine kinase numeric result, please specify
text
C0201973 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
creatine kinase character result
Item
creatine kinase character result, please specify
text
C0201973 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
lactate dehydrogenase
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0202113 (UMLS CUI [1,3])
creatine kinase
Code List
lactate dehydrogenase
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
lactate dehydrogenase numeric result
Item
lactate dehydrogenase numeric result, please specify
text
C0202113 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
lactate dehydrogenase character result
Item
lactate dehydrogenase character result, please specify
text
C0202113 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Actin (Smooth Muscle) IgG Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1532316 (UMLS CUI [1,3])
creatine kinase
Code List
Actin (Smooth Muscle) IgG Antibody
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Actin (Smooth Muscle) IgG Antibody numeric result
Item
Actin (Smooth Muscle) IgG Antibody numeric result, please specify
text
C1532316 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Actin (Smooth Muscle) IgG Antibody character result
Item
Actin (Smooth Muscle) IgG Antibody character result, please specify
text
C1532316 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody-Screen
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
creatine kinase
Code List
Anti-Nuclear Antibody-Screen
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody-Screen numeric result
Item
Anti-Nuclear Antibody-Screen numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody-Screen character result
Item
Anti-Nuclear Antibody-Screen character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
creatine kinase
Code List
Anti-Nuclear Antibody
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 2
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
creatine kinase
Code List
Anti-Nuclear Antibody 2
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 2 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 2 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 3
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
creatine kinase
Code List
Anti-Nuclear Antibody 3
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 3 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 3 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody 4
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
creatine kinase
Code List
Anti-Nuclear Antibody 4
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody numeric result
Item
Anti-Nuclear Antibody 4 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Anti-Nuclear Antibody character result
Item
Anti-Nuclear Antibody 4 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Anti-Nuclear Antibody Pattern
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
creatine kinase
Code List
Anti-Nuclear Antibody Pattern
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 2
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
creatine kinase
Code List
Anti-Nuclear Antibody Pattern 2
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 2 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 2 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 3
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
creatine kinase
Code List
Anti-Nuclear Antibody Pattern 3
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 3 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 3 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Anti-Nuclear Antibody Pattern 4
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
creatine kinase
Code List
Anti-Nuclear Antibody Pattern 4
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Anti-Nuclear Antibody Pattern numeric result
Item
Anti-Nuclear Antibody Pattern 4 numeric result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Anti-Nuclear Antibody Pattern character result
Item
Anti-Nuclear Antibody Pattern 4 character result, please specify
text
C0587178 (UMLS CUI [1,1])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Cytomegalovirus IgM Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272889 (UMLS CUI [1,3])
creatine kinase
Code List
Cytomegalovirus IgM Antibody
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Cytomegalovirus IgM Antibody numeric result
Item
Cytomegalovirus IgM Antibody numeric result, please specify
text
C3272889 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Cytomegalovirus IgM Antibody character result
Item
Cytomegalovirus IgM Antibody character result, please specify
text
C3272889 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
creatine kinase
Code List
Epstein-Barr Viral Capsid Antigen IgM Antibody
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result, please specify
text
C3272892 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
Epstein-Barr Viral Capsid Antigen IgM Antibody character result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody character result, please specify
text
C3272892 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
C0871362 (UMLS CUI [1,4])
creatine kinase
Code List
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result, please specify
text
C3272892 (UMLS CUI [1,1])
C0871362 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result
Item
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result, please specify
text
C3272892 (UMLS CUI [1,1])
C0871362 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis A IgM Antibody Total (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0373852 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
creatine kinase
Code List
Hepatitis A IgM Antibody Total (Qualitative)
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis A IgM Antibody Total (Qualitative) numeric result
Item
Hepatitis A IgM Antibody Total (Qualitative) numeric result, please specify
text
C0373852 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis A IgM Antibody Total (Qualitative) character result
Item
Hepatitis A IgM Antibody Total (Qualitative) character result, please specify
text
C0373852 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis B Core IgM Antibody (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0201480 (UMLS CUI [1,3])
C0202084 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,5])
creatine kinase
Code List
Hepatitis B Core IgM Antibody (Qualitative)
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis B Core IgM Antibody (Qualitative) numeric result
Item
Hepatitis B Core IgM Antibody (Qualitative) numeric result, please specify
text
C0201480 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
Hepatitis B Core IgM Antibody (Qualitative) character result
Item
Hepatitis B Core IgM Antibody (Qualitative) character result, please specify
text
C0201480 (UMLS CUI [1,1])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
Item
Hepatitis B Surface Antigen (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
creatine kinase
Code List
Hepatitis B Surface Antigen (Qualitative)
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis B Surface Antigen (Qualitative) numeric result
Item
Hepatitis B Surface Antigen (Qualitative) numeric result, please specify
text
C0019168 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis B Surface Antigen (Qualitative) character result
Item
Hepatitis B Surface Antigen (Qualitative) character result, please specify
text
C0019168 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis E IgM Antibody Total (Qualitative)
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C3272944 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
creatine kinase
Code List
Hepatitis E IgM Antibody Total (Qualitative)
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis E IgM Antibody Total (Qualitative) numeric result
Item
Hepatitis E IgM Antibody Total (Qualitative) numeric result, please specify
text
C3272944 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Hepatitis E IgM Antibody Total (Qualitative) character result
Item
Hepatitis E IgM Antibody Total (Qualitative) character result, please specify
text
C3272944 (UMLS CUI [1,1])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Liver Kidney Microsomal Antibody IgG
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C0051982 (UMLS CUI [1,3])
C0020852 (UMLS CUI [1,4])
creatine kinase
Code List
Liver Kidney Microsomal Antibody IgG
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Liver Kidney Microsomal Antibody IgG numeric result
Item
Liver Kidney Microsomal Antibody IgG numeric result, please specify
text
C0051982 (UMLS CUI [1,1])
C0020852 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
Liver Kidney Microsomal Antibody IgG character result
Item
Liver Kidney Microsomal Antibody IgG character result, please specify
text
C0051982 (UMLS CUI [1,1])
C0020852 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
Item
Hepatitis C RNA PCR
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C0032520 (UMLS CUI [1,4])
creatine kinase
Code List
Hepatitis C RNA PCR
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis C RNA PCR numeric result
Item
Hepatitis C RNA PCR numeric result, please specify
text
C1272251 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Hepatitis C RNA PCR character result
Item
Hepatitis C RNA PCR character result, please specify
text
C1272251 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Item
Hepatitis C RNA PCR Log
text
C1274040 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C3873230 (UMLS CUI [1,4])
creatine kinase
Code List
Hepatitis C RNA PCR Log
CL Item
numeric result (1)
CL Item
character result  (2)
CL Item
no result (3)
Hepatitis C RNA PCR Log numeric result
Item
Hepatitis C RNA PCR Log numeric result, please specify
text
C1272251 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])
Hepatitis C RNA PCR Log character result
Item
Hepatitis C RNA PCR Log character result, please specify
text
C1272251 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])
Item Group
Pharmacokinetics (Liver PK)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
pharmacokinetic blood sample date and time
Item
if yes, please specify date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
date and time of last investigational product dose
Item
if yes, please specify date and time of last investigational product dose prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
sample identifier / sample number, pharmacokinetic aspects
Item
if yes, please specify sample identifier / sample number
text
C1299222 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Item Group
Medical Conditions at Onset of Liver Event (LIVER MEDHX)
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
Item
Acute Viral Hepatitis A
text
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Liver metastases
text
C0494165 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Liver metastases
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatitis E IgM Antibody
text
C3272944 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Hepatitis E IgM Antibody
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Acute Viral Hepatitis A
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Other Liver Disease Conditions at Onset of Liver Event
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0023884 (UMLS CUI-5)
Liver disease, Sequence Number [hidden]
Item
Sequence Number [hidden]
text
C0023895 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Liver disease, Specific Condition
Item
Specific Condition
text
C0023895 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Liver disease, Modified Term [hidden]
Item
Modified Term [hidden]
text
C2826923 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Liver disease, MedDRA Synonym [hidden]
Item
MedDRA Synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
Liver disease, MedDRA lower level term code [hidden]
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
Liver disease, Failed coding [hidden]
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
Item
Status
text
C0023895 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other Medical Conditions at Onset of Liver Event
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
Item
Drug Allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Allergies
Code List
Drug Allergies
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis
Code List
Rheumatoid Arthritis
CL Item
current  (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Psoriasis
Code List
Psoriasis
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Thyroid Disease
Code List
Thyroid Disease
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Inflammatory Bowel Disease
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Lupus
Code List
Lupus
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Sjogren's Syndrome
Code List
Sjogren's Syndrome
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Vitiligo
Code List
Vitiligo
CL Item
current (1)
CL Item
past (2)
CL Item
no medical condition (5)
Item Group
Alcohol Intake at Onset of Liver Event (Liver Alcohol)
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
alcohol consumption
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
alcohol units per week
Item
if yes, record the average number of units of alcohol consumed per week
integer
C0560579 (UMLS CUI [1])
substance use type
Item
substance use type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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