ID
41886
Beschreibung
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
Stichworte
Versionen (1)
- 09.02.21 09.02.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
9. Februar 2021
DOI
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Lizenz
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
Beschreibung
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beschreibung
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.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C0030695
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C1512900
Beschreibung
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)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2746065
Beschreibung
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschreibung
Check all that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
Check all that apply
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschreibung
age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
if yes, ensure pregnancy notification form has been completed
Datentyp
text
Alias
- UMLS CUI [1]
- C0032961
Beschreibung
diagnostic imaging of the liver or hepatobiliary system
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
Beschreibung
if no, record the details on the Non-Serious-Adverse Events form or Serious Adverse Event form
Datentyp
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
Beschreibung
if yes, complete liver biopsy form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschreibung
if yes, document on the appropriate Concomitant Medication form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beschreibung
subject recently fasted or underwent significant dietary change
Datentyp
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
Beschreibung
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschreibung
liver event occurance time
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschreibung
liver event, start date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0808070
Beschreibung
liver event, end date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806020
Beschreibung
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
Beschreibung
Laboratory ID
Datentyp
text
Alias
- UMLS CUI [1]
- C2986056
Beschreibung
Laboratory name and adress
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C1301826
Beschreibung
Laboratory name and adress
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
Beschreibung
Laboratory name and adress
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C1301826
Beschreibung
date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschreibung
result type: creatine kinase
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0010287
Beschreibung
creatine kinase numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2347373
Beschreibung
creatine kinase character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: lactate dehydrogenase
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0202113
Beschreibung
lactate dehydrogenase numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2347373
Beschreibung
lactate dehydrogenase character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Actin (Smooth Muscle) IgG Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1532316
Beschreibung
Actin (Smooth Muscle) IgG Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2347373
Beschreibung
Actin (Smooth Muscle) IgG Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody-Screen
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0220908
Beschreibung
Anti-Nuclear Antibody-Screen numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2347373
Beschreibung
Anti-Nuclear Antibody-Screen character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschreibung
Anti-Nuclear Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschreibung
Anti-Nuclear Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschreibung
Anti-Nuclear Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschreibung
Anti-Nuclear Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschreibung
Anti-Nuclear Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschreibung
Anti-Nuclear Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschreibung
Anti-Nuclear Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschreibung
Anti-Nuclear Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody Pattern
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschreibung
Anti-Nuclear Antibody Pattern numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschreibung
Anti-Nuclear Antibody Pattern character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody Pattern
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschreibung
Anti-Nuclear Antibody Pattern numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschreibung
Anti-Nuclear Antibody Pattern character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody Pattern
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschreibung
Anti-Nuclear Antibody Pattern numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschreibung
Anti-Nuclear Antibody Pattern character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Anti-Nuclear Antibody Pattern
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschreibung
Anti-Nuclear Antibody Pattern numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschreibung
Anti-Nuclear Antibody Pattern character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Cytomegalovirus IgM Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272889
Beschreibung
Cytomegalovirus IgM Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2347373
Beschreibung
Cytomegalovirus IgM Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
Beschreibung
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2347373
Beschreibung
Epstein-Barr Viral Capsid Antigen IgM Antibody character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2350015
Beschreibung
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
- UMLS CUI [1,4]
- C0871362
Beschreibung
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2347373
Beschreibung
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Hepatitis A IgM Antibody Total (Qualitative)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0373852
- UMLS CUI [1,4]
- C0205556
Beschreibung
Hepatitis A IgM Antibody Total (Qualitative) numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschreibung
Hepatitis A IgM Antibody Total (Qualitative) character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Hepatitis B Core IgM Antibody (Qualitative)
Datentyp
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
Beschreibung
Hepatitis B Core IgM Antibody (Qualitative) numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2347373
Beschreibung
Hepatitis B Core IgM Antibody (Qualitative) character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2350015
Beschreibung
result type: Hepatitis B Surface Antigen (Qualitative)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0019168
- UMLS CUI [1,4]
- C0205556
Beschreibung
Hepatitis B Surface Antigen (Qualitative) numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschreibung
Hepatitis B Surface Antigen (Qualitative) character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Hepatitis E IgM Antibody Total (Qualitative)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272944
- UMLS CUI [1,4]
- C0205556
Beschreibung
Hepatitis E IgM Antibody Total (Qualitative) numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschreibung
Hepatitis E IgM Antibody Total (Qualitative) character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Liver Kidney Microsomal Antibody IgG
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0051982
- UMLS CUI [1,4]
- C0020852
Beschreibung
Liver Kidney Microsomal Antibody IgG numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2347373
Beschreibung
Liver Kidney Microsomal Antibody IgG character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2350015
Beschreibung
result type: Hepatitis C RNA PCR
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C0032520
Beschreibung
Hepatitis C RNA PCR numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C0032520
Beschreibung
Hepatitis C RNA PCR character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C0032520
Beschreibung
result type: Hepatitis C RNA PCR Log
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C3873230
Beschreibung
Hepatitis C RNA PCR Log numeric result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C3873230
Beschreibung
Hepatitis C RNA PCR Log character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C3873230
Beschreibung
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschreibung
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).
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschreibung
pharmacokinetic blood sample date and time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschreibung
date and time of last investigational product dose
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beschreibung
sample identifier / sample number, pharmacokinetic aspects
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Beschreibung
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
Beschreibung
Acute Viral Hepatitis A
Datentyp
text
Alias
- UMLS CUI [1]
- C0276434
Beschreibung
Chronic Hepatitis B
Datentyp
text
Alias
- UMLS CUI [1]
- C0524909
Beschreibung
Chronic Hepatitis C
Datentyp
text
Alias
- UMLS CUI [1]
- C0524910
Beschreibung
Cytomegalovirus Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0276252
Beschreibung
Epstein Barr Virus Infectious Mononucleosis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beschreibung
Herpes Simplex Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C1963747
Beschreibung
Alcoholic Liver Disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0023896
Beschreibung
Non-alcoholic Steatohepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C3241937
Beschreibung
Fatty Liver
Datentyp
text
Alias
- UMLS CUI [1]
- C0015695
Beschreibung
Hepatic Cirrhosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0023890
Beschreibung
Hemochromatosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0018995
Beschreibung
Autoimmune Hepatitis
Datentyp
text
Alias
- UMLS CUI [1]
- C0241910
Beschreibung
Gallbladder disease
Datentyp
text
Alias
- UMLS CUI [1]
- C0016977
Beschreibung
Liver metastases
Datentyp
text
Alias
- UMLS CUI [1]
- C0494165
Beschreibung
Hepatitis E IgM Antibody
Datentyp
text
Alias
- UMLS CUI [1]
- C3272944
Beschreibung
Drug related liver disease
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0277579
Beschreibung
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
Beschreibung
Liver disease, Sequence Number [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348184
Beschreibung
Liver disease, Specific Condition
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348235
Beschreibung
Liver disease, Modified Term [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Beschreibung
Liver disease, MedDRA Synonym [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C0023895
Beschreibung
Liver disease, MedDRA lower level term code [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0023895
Beschreibung
Liver disease, Failed coding [hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0023895
Beschreibung
Liver disease, Status
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Beschreibung
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
Beschreibung
Drug Allergies
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beschreibung
Rheumatoid Arthritis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0003873
Beschreibung
Psoriasis
Datentyp
integer
Alias
- UMLS CUI [1]
- C0033860
Beschreibung
Thyroid Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0040128
Beschreibung
Inflammatory Bowel Disease
Datentyp
integer
Alias
- UMLS CUI [1]
- C0021390
Beschreibung
Lupus
Datentyp
integer
Alias
- UMLS CUI [1]
- C0409974
Beschreibung
Sjogren's Syndrome
Datentyp
integer
Alias
- UMLS CUI [1]
- C1527336
Beschreibung
Vitiligo
Datentyp
integer
Alias
- UMLS CUI [1]
- C0042900
Beschreibung
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
Beschreibung
alcohol consumption
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
alcohol units per week
Datentyp
integer
Maßeinheiten
- alcohol units/week
Alias
- UMLS CUI [1]
- C0560579
Beschreibung
[hidden]
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439861
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0332307
Ähnliche Modelle
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])