ID

37411

Descripción

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form is to be filled in if an Adverse Liver Event occurs, and can be used for investigations such as repeat pharmacokinetic samples or specific medical history relating to this Liver Event, however there are seperate forms for Liver Imaging and Liver Biopsy (if performed).

Link

https://clinicaltrials.gov/ct2/show/NCT00996840

Palabras clave

Versiones (1)
  1. 24/7/19 24/7/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

24 de julio de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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SB-681323 in ALI/ARDS risk patients - NCT00996840

Inglés

Liver Events

1 formularios  
  1. StudyEvent: ODM
    1. Liver Events
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Descripción

Date/Time of Assessment

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Liver Events - Lab
Descripción

Liver Events - Lab

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0008000
Has ALT (alanine aminotransferase) result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

ALT reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has AST (aspartate aminotransferase) result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

AST reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has total bilirubin result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Total bilirubin reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has alkaline phosphatase result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Alkaline phosphatase reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has 5' nucleotidase result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

5' nucleotidase reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0202148
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has gamma-glutamyltranspeptidase result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Gamma-glutamyltranspeptidase reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Has another liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Descripción

Other liver chemistry result reached stopping criteria

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0008000
UMLS CUI [1,4]
C0304229
UMLS CUI [1,5]
C2746065
UMLS CUI [1,6]
C0243161
Liver Events - Clinical
Descripción

Liver Events - Clinical

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0205210
Is the subject age 55 or older?
Descripción

Age

Tipo de datos

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Tipo de datos

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)?
Descripción

f Yes, answer whether the results were normal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
UMLS CUI [3]
C0412534
UMLS CUI [4]
C0412620
UMLS CUI [5]
C0412693
UMLS CUI [6]
C0008310
Were the results of diagnostic imaging tests of the liver or hepatobiliary system normal?
Descripción

If applicable If No, record the details on the Non-Serious Adverse Events form or Serious Adverse Event form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0456984
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0456984
UMLS CUI [2,3]
C0023884
Were any liver biopsies performed?
Descripción

If yes, complete Liver Biopsy form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C1272695
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Descripción

If yes, record on the appropriate Concomitant Medication form.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2347852
UMLS CUI [2]
C0025125
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Descripción

Recent fasting or significant dietary change

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0015663
Evaluation interval code [hidden]
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826267
Investigational Product Liver
Descripción

Investigational Product Liver

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
Is Start Date of Investigational Product applicable?
Descripción

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1706839
Start Date of Investigational Product applicable
Descripción

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. If applicale

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0013230
Is End Date of Investigational Product applicable?
Descripción

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1706839
End Date of Investigational Product
Descripción

If the liver event occurred during treatment period record start and stop date of investigational product for that treatment period. If the liver event occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event.

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C3899266
UMLS CUI [1,2]
C0013230
Pharmakokinetics Liver
Descripción

Pharmakokinetics Liver

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031327
UMLS CUI-3
C0023884
Was a pharmacokinetic blood sample obtained?
Descripción

An unscheduled PK blood sample must be obtained within 2 hours of last dose. If yes, answer following three items.

Tipo de datos

boolean

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

if applicable

Tipo de datos

datetime

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

if applicable

Tipo de datos

datetime

Alias
UMLS CUI [1,1]
C0945778
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0031328
Sample Identifier of pharmacokinetic blood sample
Descripción

if applicable

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1299222
Liver disease medical conditions
Descripción

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Descripción

Acute type A viral hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Descripción

Hepatitis B, Chronic

Tipo de datos

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Descripción

Hepatitis C, Chronic

Tipo de datos

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Descripción

Cytomegalovirus Hepatitis

Tipo de datos

integer

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

Infectious Mononucleosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0021345
Herpes Simplex Hepatitis
Descripción

Herpes Simplex Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Descripción

Alcoholic Liver Diseases

Tipo de datos

integer

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

Non-alcoholic Steatohepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Descripción

Fatty Liver

Tipo de datos

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Descripción

Hepatic Cirrhosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Descripción

Hemochromatosis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Descripción

Autoimmune Hepatitis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Descripción

Gall Bladder Diseases

Tipo de datos

integer

Alias
UMLS CUI [1]
C0016977
Drug related liver disease conditions
Descripción

Drug related liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0041755
Drug related liver disease
Descripción

Drug related liver disease

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0041755
Other Liver Disease
Descripción

Other Liver Disease

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Sequence Number [hidden]
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2348184
Other Liver Disease Conditions - Specific Condition
Descripción

Other liver disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
Modified Term [hidden]
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym [hidden]
Descripción

[hidden]

Tipo de datos

text

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

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1]
C3898442
Failed coding [hidden]
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Other Liver Disease Conditions - Status
Descripción

Other Liver Disease Conditions - Status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other medical conditions
Descripción

Other medical conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0205394
Drug Allergies
Descripción

Drug Allergies

Tipo de datos

integer

Alias
UMLS CUI [1]
C0013182
Rheumatoid Arthritis
Descripción

Rheumatoid Arthritis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Descripción

Psoriasis

Tipo de datos

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Descripción

Thyroid Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Descripción

Inflammatory Bowel Disease

Tipo de datos

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Descripción

Lupus

Tipo de datos

integer

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

Sjogren's Syndrome

Tipo de datos

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Descripción

Vitiligo

Tipo de datos

integer

Alias
UMLS CUI [1]
C0042900
Alcohol Intake
Descripción

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Descripción

If Yes, record the average number of units of alcohol consumed per week

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001948
Record the average number of units of alcohol consumed per week
Descripción

if applicable

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
UMLS CUI [1,3]
C1510992
Substance Use Type [hidden]
Descripción

[hidden]

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0332307
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Similar models

Liver Events

1 formularios
  1. StudyEvent: ODM
    1. Liver Events
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Liver Events - Lab
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
ALT reached stopping criteria
Item
Has ALT (alanine aminotransferase) result reached or exceeded 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])
AST reached stopping criteria
Item
Has AST (aspartate aminotransferase) result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201899 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Total bilirubin reached stopping criteria
Item
Has total bilirubin result reached or exceeded 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])
Alkaline phosphatase reached stopping criteria
Item
Has alkaline phosphatase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0201850 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
5' nucleotidase reached stopping criteria
Item
Has 5' nucleotidase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0202148 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Gamma-glutamyltranspeptidase reached stopping criteria
Item
Has gamma-glutamyltranspeptidase result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0202035 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Other liver chemistry result reached stopping criteria
Item
Has another liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
boolean
C0205394 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0243161 (UMLS CUI [1,6])
Item Group
Liver Events - Clinical
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0205210 (UMLS CUI-3)
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])
Pregnancy
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
diagnostic imaging of liver or hepatobiliary system perfomed, e.g. liver ultrasound, CT, MRI, ERCP
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])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0412534 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0412693 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
results of diagnostic imaging of liver or hepatobiliary system
Item
Were the results of diagnostic imaging tests of the liver or hepatobiliary system normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0456984 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1,1])
C1272695 (UMLS CUI [1,2])
Concomitant Medication incl. herbals, food supplements, illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C2347852 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0086190 (UMLS CUI [4])
Recent fasting or significant dietary change
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C0015663 (UMLS CUI [2,2])
Evaluation interval code
Item
Evaluation interval code [hidden]
text
C2826267 (UMLS CUI [1])
Item Group
Investigational Product Liver
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Start Date Investigational Product applicable
Item
Is Start Date of Investigational Product applicable?
boolean
C3897500 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
Start Date Investigational Product
Item
Start Date of Investigational Product applicable
datetime
C3897500 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
End Date Investigational Product applicable
Item
Is End Date of Investigational Product applicable?
boolean
C3899266 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1706839 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date of Investigational Product
datetime
C3899266 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item Group
Pharmakokinetics Liver
C0005834 (UMLS CUI-1)
C0031327 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
pharmacokinetic blood sample
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date/Time of pharmacokinetic blood sample
Item
date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date/Time of last investigational product dose prior to pharmacokinetic blood sample
Item
date and time of last investigational product dose prior to PK sample
datetime
C0945778 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
pharmacokinetic blood sample identifier
Item
Sample Identifier of pharmacokinetic blood sample
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Item Group
Liver disease medical conditions
C0023895 (UMLS CUI-1)
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1])
Acute type A viral hepatitis
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
integer
C1963747 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug related liver disease conditions
C0023895 (UMLS CUI-1)
C0041755 (UMLS CUI-2)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Acute type A viral hepatitis
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
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number [hidden]
text
C2348184 (UMLS CUI [1])
Other liver disease
Item
Other Liver Disease Conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Modified Term
Item
Modified Term [hidden]
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym [hidden]
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code [hidden]
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding [hidden]
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Other Liver Disease Conditions - Status
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Liver diseases; Other, Status
Code List
Other Liver Disease Conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Drug Allergies
integer
C0013182 (UMLS CUI [1])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
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])
Acute type A viral hepatitis
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Does subject consume alcohol
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
average number of units of alcohol consumed per week
Item
Record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
C1510992 (UMLS CUI [1,3])
Substance Use Type
Item
Substance Use Type [hidden]
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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