ID
41886
Beskrivning
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.
Länk
https://clinicaltrials.gov/ct2/show/NCT00821054
Nyckelord
Versioner (1)
- 2021-02-09 2021-02-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 februari 2021
DOI
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Licens
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
Liver Events Assessment
- StudyEvent: ODM
Beskrivning
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beskrivning
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.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C0030695
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C1512900
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2746065
Beskrivning
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
Check all that apply
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beskrivning
age
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
if yes, ensure pregnancy notification form has been completed
Datatyp
text
Alias
- UMLS CUI [1]
- C0032961
Beskrivning
diagnostic imaging of the liver or hepatobiliary system
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
Beskrivning
if no, record the details on the Non-Serious-Adverse Events form or Serious Adverse Event form
Datatyp
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
Beskrivning
if yes, complete liver biopsy form
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beskrivning
if yes, document on the appropriate Concomitant Medication form
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beskrivning
subject recently fasted or underwent significant dietary change
Datatyp
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
Beskrivning
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beskrivning
liver event occurance time
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beskrivning
liver event, start date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0808070
Beskrivning
liver event, end date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806020
Beskrivning
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
Beskrivning
Laboratory ID
Datatyp
text
Alias
- UMLS CUI [1]
- C2986056
Beskrivning
Laboratory name and adress
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C1301826
Beskrivning
Laboratory name and adress
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
Beskrivning
Laboratory name and adress
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C1301826
Beskrivning
date and time sample taken
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beskrivning
result type: creatine kinase
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0010287
Beskrivning
creatine kinase numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2347373
Beskrivning
creatine kinase character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: lactate dehydrogenase
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0202113
Beskrivning
lactate dehydrogenase numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2347373
Beskrivning
lactate dehydrogenase character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Actin (Smooth Muscle) IgG Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1532316
Beskrivning
Actin (Smooth Muscle) IgG Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2347373
Beskrivning
Actin (Smooth Muscle) IgG Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody-Screen
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0220908
Beskrivning
Anti-Nuclear Antibody-Screen numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2347373
Beskrivning
Anti-Nuclear Antibody-Screen character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beskrivning
Anti-Nuclear Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beskrivning
Anti-Nuclear Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beskrivning
Anti-Nuclear Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beskrivning
Anti-Nuclear Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beskrivning
Anti-Nuclear Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beskrivning
Anti-Nuclear Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beskrivning
Anti-Nuclear Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beskrivning
Anti-Nuclear Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody Pattern
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beskrivning
Anti-Nuclear Antibody Pattern numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beskrivning
Anti-Nuclear Antibody Pattern character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody Pattern
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beskrivning
Anti-Nuclear Antibody Pattern numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beskrivning
Anti-Nuclear Antibody Pattern character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody Pattern
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beskrivning
Anti-Nuclear Antibody Pattern numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beskrivning
Anti-Nuclear Antibody Pattern character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Anti-Nuclear Antibody Pattern
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beskrivning
Anti-Nuclear Antibody Pattern numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beskrivning
Anti-Nuclear Antibody Pattern character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Cytomegalovirus IgM Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272889
Beskrivning
Cytomegalovirus IgM Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2347373
Beskrivning
Cytomegalovirus IgM Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
Beskrivning
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2347373
Beskrivning
Epstein-Barr Viral Capsid Antigen IgM Antibody character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2350015
Beskrivning
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
- UMLS CUI [1,4]
- C0871362
Beskrivning
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2347373
Beskrivning
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Hepatitis A IgM Antibody Total (Qualitative)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0373852
- UMLS CUI [1,4]
- C0205556
Beskrivning
Hepatitis A IgM Antibody Total (Qualitative) numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beskrivning
Hepatitis A IgM Antibody Total (Qualitative) character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Hepatitis B Core IgM Antibody (Qualitative)
Datatyp
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
Beskrivning
Hepatitis B Core IgM Antibody (Qualitative) numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2347373
Beskrivning
Hepatitis B Core IgM Antibody (Qualitative) character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2350015
Beskrivning
result type: Hepatitis B Surface Antigen (Qualitative)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0019168
- UMLS CUI [1,4]
- C0205556
Beskrivning
Hepatitis B Surface Antigen (Qualitative) numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beskrivning
Hepatitis B Surface Antigen (Qualitative) character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Hepatitis E IgM Antibody Total (Qualitative)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272944
- UMLS CUI [1,4]
- C0205556
Beskrivning
Hepatitis E IgM Antibody Total (Qualitative) numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beskrivning
Hepatitis E IgM Antibody Total (Qualitative) character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Liver Kidney Microsomal Antibody IgG
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0051982
- UMLS CUI [1,4]
- C0020852
Beskrivning
Liver Kidney Microsomal Antibody IgG numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2347373
Beskrivning
Liver Kidney Microsomal Antibody IgG character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2350015
Beskrivning
result type: Hepatitis C RNA PCR
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C0032520
Beskrivning
Hepatitis C RNA PCR numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C0032520
Beskrivning
Hepatitis C RNA PCR character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C0032520
Beskrivning
result type: Hepatitis C RNA PCR Log
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C3873230
Beskrivning
Hepatitis C RNA PCR Log numeric result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C3873230
Beskrivning
Hepatitis C RNA PCR Log character result
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C3873230
Beskrivning
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beskrivning
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).
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beskrivning
pharmacokinetic blood sample date and time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beskrivning
date and time of last investigational product dose
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beskrivning
sample identifier / sample number, pharmacokinetic aspects
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Beskrivning
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
Beskrivning
Acute Viral Hepatitis A
Datatyp
text
Alias
- UMLS CUI [1]
- C0276434
Beskrivning
Chronic Hepatitis B
Datatyp
text
Alias
- UMLS CUI [1]
- C0524909
Beskrivning
Chronic Hepatitis C
Datatyp
text
Alias
- UMLS CUI [1]
- C0524910
Beskrivning
Cytomegalovirus Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0276252
Beskrivning
Epstein Barr Virus Infectious Mononucleosis
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beskrivning
Herpes Simplex Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C1963747
Beskrivning
Alcoholic Liver Disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0023896
Beskrivning
Non-alcoholic Steatohepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C3241937
Beskrivning
Fatty Liver
Datatyp
text
Alias
- UMLS CUI [1]
- C0015695
Beskrivning
Hepatic Cirrhosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0023890
Beskrivning
Hemochromatosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0018995
Beskrivning
Autoimmune Hepatitis
Datatyp
text
Alias
- UMLS CUI [1]
- C0241910
Beskrivning
Gallbladder disease
Datatyp
text
Alias
- UMLS CUI [1]
- C0016977
Beskrivning
Liver metastases
Datatyp
text
Alias
- UMLS CUI [1]
- C0494165
Beskrivning
Hepatitis E IgM Antibody
Datatyp
text
Alias
- UMLS CUI [1]
- C3272944
Beskrivning
Drug related liver disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0277579
Beskrivning
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
Beskrivning
Liver disease, Sequence Number [hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348184
Beskrivning
Liver disease, Specific Condition
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348235
Beskrivning
Liver disease, Modified Term [hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Beskrivning
Liver disease, MedDRA Synonym [hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C0023895
Beskrivning
Liver disease, MedDRA lower level term code [hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0023895
Beskrivning
Liver disease, Failed coding [hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0023895
Beskrivning
Liver disease, Status
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Beskrivning
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
Beskrivning
Drug Allergies
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beskrivning
Rheumatoid Arthritis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beskrivning
Psoriasis
Datatyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beskrivning
Thyroid Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beskrivning
Inflammatory Bowel Disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Lupus
Datatyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beskrivning
Sjogren's Syndrome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beskrivning
Vitiligo
Datatyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beskrivning
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
Beskrivning
alcohol consumption
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
alcohol units per week
Datatyp
integer
Måttenheter
- alcohol units/week
Alias
- UMLS CUI [1]
- C0560579
Beskrivning
[hidden]
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Similar models
Liver Events Assessment
- StudyEvent: ODM
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0030695 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
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])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
C0015663 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C3671772 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0877248 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0205276 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0027365 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C1301826 (UMLS CUI [2,2])
C0027365 (UMLS CUI [1,2])
C1301826 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0332307 (UMLS CUI [1,2])
C0010287 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0202113 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1532316 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,4])
C0220908 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0220908 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0587178 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,4])
C0449774 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0449774 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C3272889 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C3272892 (UMLS CUI [1,3])
C0871362 (UMLS CUI [1,4])
C0871362 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0871362 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0373852 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0201480 (UMLS CUI [1,3])
C0202084 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,5])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,4])
C0202084 (UMLS CUI [1,2])
C0205556 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C0019168 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C3272944 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,4])
C0205556 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0205556 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C0051982 (UMLS CUI [1,3])
C0020852 (UMLS CUI [1,4])
C0020852 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C0020852 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C0032520 (UMLS CUI [1,4])
C2347373 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C1272251 (UMLS CUI [1,3])
C3873230 (UMLS CUI [1,4])
C2347373 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])
C2350015 (UMLS CUI [1,2])
C3873230 (UMLS CUI [1,3])
C0023884 (UMLS CUI-2)
C0031328 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0031328 (UMLS CUI [1,2])
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0014644 (UMLS CUI [1,2])
C0277579 (UMLS CUI [1,2])
C0205394 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0023884 (UMLS CUI-5)
C2348184 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0023895 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0023884 (UMLS CUI-2)
C0332162 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])