ID
41886
Beschrijving
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
Trefwoorden
Versies (1)
- 09-02-21 09-02-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 februari 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Liver Events Assessment
- StudyEvent: ODM
Beschrijving
Liver Events Assessment
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C0030695
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C1512900
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [1,3]
- C0877248
- UMLS CUI [1,4]
- C2746065
Beschrijving
Liver Events
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
Check all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
Check all that apply
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2746065
- UMLS CUI [1,4]
- C0243161
Beschrijving
age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
if yes, ensure pregnancy notification form has been completed
Datatype
text
Alias
- UMLS CUI [1]
- C0032961
Beschrijving
diagnostic imaging of the liver or hepatobiliary system
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0011923
- UMLS CUI [1,2]
- C0023884
- UMLS CUI [2,1]
- C0011923
- UMLS CUI [2,2]
- C1711359
Beschrijving
if no, record the details on the Non-Serious-Adverse Events form or Serious Adverse Event form
Datatype
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
Beschrijving
if yes, complete liver biopsy form
Datatype
boolean
Alias
- UMLS CUI [1]
- C0193388
Beschrijving
if yes, document on the appropriate Concomitant Medication form
Datatype
boolean
Alias
- UMLS CUI [1]
- C2240391
- UMLS CUI [2]
- C1148474
- UMLS CUI [3]
- C0002346
- UMLS CUI [4]
- C0242295
- UMLS CUI [5]
- C0086190
Beschrijving
subject recently fasted or underwent significant dietary change
Datatype
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
Beschrijving
Investigational Product (Liver)
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0023884
Beschrijving
liver event occurance time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [1,4]
- C0011008
Beschrijving
liver event, start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0808070
Beschrijving
liver event, end date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0806020
Beschrijving
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
Beschrijving
Laboratory ID
Datatype
text
Alias
- UMLS CUI [1]
- C2986056
Beschrijving
Laboratory name and adress
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C1301826
Beschrijving
Laboratory name and adress
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0027365
Beschrijving
Laboratory name and adress
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C1301826
Beschrijving
date and time sample taken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beschrijving
result type: creatine kinase
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0010287
Beschrijving
creatine kinase numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2347373
Beschrijving
creatine kinase character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201973
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: lactate dehydrogenase
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0202113
Beschrijving
lactate dehydrogenase numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2347373
Beschrijving
lactate dehydrogenase character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Actin (Smooth Muscle) IgG Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1532316
Beschrijving
Actin (Smooth Muscle) IgG Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2347373
Beschrijving
Actin (Smooth Muscle) IgG Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1532316
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody-Screen
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0220908
Beschrijving
Anti-Nuclear Antibody-Screen numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2347373
Beschrijving
Anti-Nuclear Antibody-Screen character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschrijving
Anti-Nuclear Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschrijving
Anti-Nuclear Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschrijving
Anti-Nuclear Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschrijving
Anti-Nuclear Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschrijving
Anti-Nuclear Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschrijving
Anti-Nuclear Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
Beschrijving
Anti-Nuclear Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2347373
Beschrijving
Anti-Nuclear Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody Pattern
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschrijving
Anti-Nuclear Antibody Pattern numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschrijving
Anti-Nuclear Antibody Pattern character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody Pattern
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschrijving
Anti-Nuclear Antibody Pattern numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschrijving
Anti-Nuclear Antibody Pattern character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody Pattern
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschrijving
Anti-Nuclear Antibody Pattern numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschrijving
Anti-Nuclear Antibody Pattern character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Anti-Nuclear Antibody Pattern
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0587178
- UMLS CUI [1,4]
- C0449774
Beschrijving
Anti-Nuclear Antibody Pattern numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2347373
Beschrijving
Anti-Nuclear Antibody Pattern character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0587178
- UMLS CUI [1,2]
- C0449774
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Cytomegalovirus IgM Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272889
Beschrijving
Cytomegalovirus IgM Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2347373
Beschrijving
Cytomegalovirus IgM Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272889
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
Beschrijving
Epstein-Barr Viral Capsid Antigen IgM Antibody numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2347373
Beschrijving
Epstein-Barr Viral Capsid Antigen IgM Antibody character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C2350015
Beschrijving
result type: Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272892
- UMLS CUI [1,4]
- C0871362
Beschrijving
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2347373
Beschrijving
Epstein-Barr Viral Capsid Antigen IgM Antibody Strength of Signal character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272892
- UMLS CUI [1,2]
- C0871362
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Hepatitis A IgM Antibody Total (Qualitative)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0373852
- UMLS CUI [1,4]
- C0205556
Beschrijving
Hepatitis A IgM Antibody Total (Qualitative) numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschrijving
Hepatitis A IgM Antibody Total (Qualitative) character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0373852
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Hepatitis B Core IgM Antibody (Qualitative)
Datatype
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
Beschrijving
Hepatitis B Core IgM Antibody (Qualitative) numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2347373
Beschrijving
Hepatitis B Core IgM Antibody (Qualitative) character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0201480
- UMLS CUI [1,2]
- C0202084
- UMLS CUI [1,3]
- C0205556
- UMLS CUI [1,4]
- C2350015
Beschrijving
result type: Hepatitis B Surface Antigen (Qualitative)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0019168
- UMLS CUI [1,4]
- C0205556
Beschrijving
Hepatitis B Surface Antigen (Qualitative) numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschrijving
Hepatitis B Surface Antigen (Qualitative) character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0019168
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Hepatitis E IgM Antibody Total (Qualitative)
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C3272944
- UMLS CUI [1,4]
- C0205556
Beschrijving
Hepatitis E IgM Antibody Total (Qualitative) numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2347373
Beschrijving
Hepatitis E IgM Antibody Total (Qualitative) character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C3272944
- UMLS CUI [1,2]
- C0205556
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Liver Kidney Microsomal Antibody IgG
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0051982
- UMLS CUI [1,4]
- C0020852
Beschrijving
Liver Kidney Microsomal Antibody IgG numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2347373
Beschrijving
Liver Kidney Microsomal Antibody IgG character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0051982
- UMLS CUI [1,2]
- C0020852
- UMLS CUI [1,3]
- C2350015
Beschrijving
result type: Hepatitis C RNA PCR
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C0032520
Beschrijving
Hepatitis C RNA PCR numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C0032520
Beschrijving
Hepatitis C RNA PCR character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C0032520
Beschrijving
result type: Hepatitis C RNA PCR Log
Datatype
text
Alias
- UMLS CUI [1,1]
- C1274040
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1272251
- UMLS CUI [1,4]
- C3873230
Beschrijving
Hepatitis C RNA PCR Log numeric result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2347373
- UMLS CUI [1,3]
- C3873230
Beschrijving
Hepatitis C RNA PCR Log character result
Datatype
text
Alias
- UMLS CUI [1,1]
- C1272251
- UMLS CUI [1,2]
- C2350015
- UMLS CUI [1,3]
- C3873230
Beschrijving
Pharmacokinetics (Liver PK)
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0023884
Beschrijving
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).
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
Beschrijving
pharmacokinetic blood sample date and time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1264639
Beschrijving
date and time of last investigational product dose
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beschrijving
sample identifier / sample number, pharmacokinetic aspects
Datatype
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
Beschrijving
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
Beschrijving
Acute Viral Hepatitis A
Datatype
text
Alias
- UMLS CUI [1]
- C0276434
Beschrijving
Chronic Hepatitis B
Datatype
text
Alias
- UMLS CUI [1]
- C0524909
Beschrijving
Chronic Hepatitis C
Datatype
text
Alias
- UMLS CUI [1]
- C0524910
Beschrijving
Cytomegalovirus Hepatitis
Datatype
text
Alias
- UMLS CUI [1]
- C0276252
Beschrijving
Epstein Barr Virus Infectious Mononucleosis
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021345
- UMLS CUI [1,2]
- C0014644
Beschrijving
Herpes Simplex Hepatitis
Datatype
text
Alias
- UMLS CUI [1]
- C1963747
Beschrijving
Alcoholic Liver Disease
Datatype
text
Alias
- UMLS CUI [1]
- C0023896
Beschrijving
Non-alcoholic Steatohepatitis
Datatype
text
Alias
- UMLS CUI [1]
- C3241937
Beschrijving
Fatty Liver
Datatype
text
Alias
- UMLS CUI [1]
- C0015695
Beschrijving
Hepatic Cirrhosis
Datatype
text
Alias
- UMLS CUI [1]
- C0023890
Beschrijving
Hemochromatosis
Datatype
text
Alias
- UMLS CUI [1]
- C0018995
Beschrijving
Autoimmune Hepatitis
Datatype
text
Alias
- UMLS CUI [1]
- C0241910
Beschrijving
Gallbladder disease
Datatype
text
Alias
- UMLS CUI [1]
- C0016977
Beschrijving
Liver metastases
Datatype
text
Alias
- UMLS CUI [1]
- C0494165
Beschrijving
Hepatitis E IgM Antibody
Datatype
text
Alias
- UMLS CUI [1]
- C3272944
Beschrijving
Drug related liver disease
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0277579
Beschrijving
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
Beschrijving
Liver disease, Sequence Number [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348184
Beschrijving
Liver disease, Specific Condition
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C2348235
Beschrijving
Liver disease, Modified Term [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C2826923
- UMLS CUI [1,2]
- C0023895
Beschrijving
Liver disease, MedDRA Synonym [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C1140263
- UMLS CUI [1,2]
- C0871468
- UMLS CUI [1,3]
- C0023895
Beschrijving
Liver disease, MedDRA lower level term code [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C3898442
- UMLS CUI [1,2]
- C0023895
Beschrijving
Liver disease, Failed coding [hidden]
Datatype
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
- UMLS CUI [1,3]
- C0023895
Beschrijving
Liver disease, Status
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023895
- UMLS CUI [1,2]
- C0449438
Beschrijving
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
Beschrijving
Drug Allergies
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0013227
Beschrijving
Rheumatoid Arthritis
Datatype
integer
Alias
- UMLS CUI [1]
- C0003873
Beschrijving
Psoriasis
Datatype
integer
Alias
- UMLS CUI [1]
- C0033860
Beschrijving
Thyroid Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0040128
Beschrijving
Inflammatory Bowel Disease
Datatype
integer
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Lupus
Datatype
integer
Alias
- UMLS CUI [1]
- C0409974
Beschrijving
Sjogren's Syndrome
Datatype
integer
Alias
- UMLS CUI [1]
- C1527336
Beschrijving
Vitiligo
Datatype
integer
Alias
- UMLS CUI [1]
- C0042900
Beschrijving
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
Beschrijving
alcohol consumption
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
alcohol units per week
Datatype
integer
Maateenheden
- alcohol units/week
Alias
- UMLS CUI [1]
- C0560579
Beschrijving
[hidden]
Datatype
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])