ID

38516

Description

Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Liver events form. It has to be filled in if a liver events occurs during the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00833989

Keywords

Versions (2)
  1. 10/5/19 10/5/19 -
  2. 10/23/19 10/23/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 23, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989

English

Liver events

1 forms  
  1. StudyEvent: ODM
    1. Liver events
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Liver events
Description

Liver events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? ALT (alanine aminotransferase)
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0201836
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? AST (aspartate aminotransferase)
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0201899
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Total bilirubin
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0201913
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Alkaline phosphatase
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0201850
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? 5' nucleotidase
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C2700357
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Gammaglutamyltranspeptidase
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0017040
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Other
Description

Check all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [1,4]
C0444930
UMLS CUI [1,5]
C0304229
UMLS CUI [2]
C0205394
Is the subject age 55 or older?
Description

Age

Data type

text

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

Ensure pregnancy notification form has been completed.

Data type

text

Alias
UMLS CUI [1]
C0032961
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic resonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Description

If you tick Yes, please specify if the results were normal in the following item.

Data type

text

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
Normal results of imaging tests
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0086143
UMLS CUI [1,2]
C0456984
UMLS CUI [1,3]
C0205307
Were any liver biopsies performed?
Description

If you tick Yes, complete Liver Biopsy form.

Data type

text

Alias
UMLS CUI [1,1]
C1518965
UMLS CUI [1,2]
C0193388
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
Description

If you tick Yes, record on the appropriate Concomitant Medication form.

Data type

text

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C1148474
UMLS CUI [3]
C0002346
UMLS CUI [4]
C0242295
UMLS CUI [5]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Description

Fasting, dietary change

Data type

text

Alias
UMLS CUI [1]
C3671772
UMLS CUI [2]
C0015663
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
Occurrence of liver event
Description

If liver event occurred Day 1 through Day 10, record the IP start and stop date of the most recent dose. If liver event occurred after Day 10, record the IP start and stop date of the Day 10 dose.

Data type

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C2697887
Start Date Investigational Product
Description

day month year. If there was no application tick the Item "Investigational Product not applicable".

Data type

partialDate

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
Start date, Investigational Product not applicable
Description

Start date, Investigational Product not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1272460
End Date Investigational Product
Description

day month year. If there was no application tick the Item "Investigational Product not applicable".

Data type

partialDate

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
End date, Investigational Product not applicable
Description

End date, Investigational Product not applicable

Data type

boolean

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1272460
Pharmacokinetics (Liver)
Description

Pharmacokinetics (Liver)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0023884
Relative time unscheduled PK blood sample has been obtained
Description

An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0005834
UMLS CUI [1,3]
C0201734
Was a pharmacokinetic blood sample obtained? (24 Hours)
Description

An unscheduled PK blood sample must be obtained within 24 hours of observation and 7 days thereafter. If you tick Yes, please specify the date and time sample taken as well as the date and time of last investigational product dose prior to PK sample in the following items.

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
Date of sample taken
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Time of sample taken
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Date of last investigational product dose prior to PK sample
Description

day month year Only has to be filled in for 24 hours of observation.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0031328
Time of last investigational product dose prior to PK sample
Description

00:00-23:59 Only has to be filled in for 24 hours of observation.

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0946444
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C0005834
UMLS CUI [1,5]
C0031328
Liver disease medical condition
Description

Liver disease medical condition

Alias
UMLS CUI-1
C0023895
Medical Condition, Liver
Description

Medical Condition, Liver

Data type

integer

Alias
UMLS CUI [1]
C0023895
Status of disease
Description

current

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438
Drug related liver disease condition
Description

Drug related liver disease condition

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0277579
Drug related liver disease
Description

Drug related liver disease

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
UMLS CUI [1,3]
C0699749
Other liver disease condition
Description

Other liver disease condition

Alias
UMLS CUI-1
C3843040
UMLS CUI-2
C0023895
Other Liver disease condition, specific condition
Description

Specific condition

Data type

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Sequence Number
Description

In the original form this item is hidden.

Data type

integer

Alias
UMLS CUI [1]
C2348184
Modified Term
Description

In the original form this item is hidden.

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

In the original form this item is hidden.

Data type

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Status of other liver disease
Description

Status of other liver disease

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0449438
Other medical condition
Description

Other medical condition

Alias
UMLS CUI-1
C3843040
Other medical condition
Description

Other medical condition

Data type

integer

Alias
UMLS CUI [1]
C3843040
Status of disease
Description

Status of disease

Data type

integer

Alias
UMLS CUI [1]
C0699749
Alcohol intake (Liver alcohol)
Description

Alcohol intake (Liver alcohol)

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C0023884
Does the subject consume alcohol?
Description

If you tick Yes, record the average number of units of alcohol consumed per week in the following item.

Data type

text

Alias
UMLS CUI [1]
C0001948
Average number of units of alcohol consumed per week
Description

Average alcohol consumption

Data type

float

Measurement units
  • units per week
Alias
UMLS CUI [1,1]
C0560579
UMLS CUI [1,2]
C1510992
units per week
Substance Use Type
Description

Will be calculated by InForm.

Data type

text

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

Liver events

1 forms
  1. StudyEvent: ODM
    1. Liver events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Liver events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Liver chemistry result stopping investigational product: ALT
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? ALT (alanine aminotransferase)
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201836 (UMLS CUI [2])
Liver chemistry result stopping investigational product: AST
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? AST (aspartate aminotransferase)
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201899 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Total bilirubin
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Total bilirubin
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201913 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Alkaline phosphatase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Alkaline phosphatase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0201850 (UMLS CUI [2])
Liver chemistry result stopping investigational product: 5' nucleotidase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? 5' nucleotidase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C2700357 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Gammaglutamyltranspeptidase
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Gammaglutamyltranspeptidase
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0017040 (UMLS CUI [2])
Liver chemistry result stopping investigational product: Other
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria? Other
boolean
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C0205394 (UMLS CUI [2])
Item
Is the subject age 55 or older?
text
C0001779 (UMLS CUI [1])
Age
Code List
Is the subject age 55 or older?
CL Item
Yes (Y)
CL Item
No (N)
Item
If female, is the subject pregnant?
text
C0032961 (UMLS CUI [1])
Age
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
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)?
text
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
Age
Code List
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)?
CL Item
Yes (Y)
CL Item
No (N)
Item
Normal results of imaging tests
text
C0086143 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,3])
Age
Code List
Normal results of imaging tests
CL Item
Yes (Y)
CL Item
No (N)
Item
Were any liver biopsies performed?
text
C1518965 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Age
Code List
Were any liver biopsies performed?
CL Item
Yes (Y)
CL Item
No (N)
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
text
C1360419 (UMLS CUI [1])
C1148474 (UMLS CUI [2])
C0002346 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
Age
Code List
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
CL Item
Yes (Y)
CL Item
No (N)
Item
Did the subject fast or undergo significant dietary change in the past week?
text
C3671772 (UMLS CUI [1])
C0015663 (UMLS CUI [2])
Age
Code List
Did the subject fast or undergo significant dietary change in the past week?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Occurrence of liver event
integer
C0023884 (UMLS CUI [1,1])
C2697887 (UMLS CUI [1,2])
Occurrence of liver event
Code List
Occurrence of liver event
CL Item
Day 1 through Day 10 (1)
CL Item
After Day 10 (2)
Start Date Investigational Product
Item
Start Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start date, Investigational Product not applicable
Item
Start date, Investigational Product not applicable
boolean
C0808070 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date Investigational Product
partialDate
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End date, Investigational Product not applicable
Item
End date, Investigational Product not applicable
boolean
C0806020 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item Group
Pharmacokinetics (Liver)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Relative time unscheduled PK blood sample has been obtained
integer
C0439564 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,3])
Relative time unscheduled PK blood sample has been obtained
Code List
Relative time unscheduled PK blood sample has been obtained
CL Item
24 hours (1)
CL Item
7 days (2)
Item
Was a pharmacokinetic blood sample obtained? (24 Hours)
text
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Age
Code List
Was a pharmacokinetic blood sample obtained? (24 Hours)
CL Item
Yes (Y)
CL Item
No (N)
Date of sample taken
Item
Date of sample taken
date
C1302413 (UMLS CUI [1])
Time of sample taken
Item
Time of sample taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Date of last investigational product dose prior to PK sample
Item
Date of last investigational product dose prior to PK sample
date
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
Time of last investigational product dose prior to PK sample
Item
Time of last investigational product dose prior to PK sample
time
C0304229 (UMLS CUI [1,1])
C0946444 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,5])
Item Group
Liver disease medical condition
C0023895 (UMLS CUI-1)
Item
Medical Condition, Liver
integer
C0023895 (UMLS CUI [1])
Medical Condition, Liver
Code List
Medical Condition, Liver
CL Item
Acute Viral Hepatitis A (1)
CL Item
Chronic Hepatitis B (2)
CL Item
Chronic Hepatitis C (3)
CL Item
Cytomegalovirus Hepatitis  (4)
CL Item
Epstein Barr Virus Infectious Mononucleosis (5)
CL Item
Herpes Simplex Hepatitis (6)
CL Item
Alcoholic Liver Disease (7)
CL Item
Non-alcoholic Steatohepatitis (8)
CL Item
Fatty Liver (9)
CL Item
Hepatic Cirrhosis (10)
CL Item
Hemochromatosis (11)
CL Item
Autoimmune Hepatitis (12)
CL Item
Gallbladder disease (13)
Item
Status of disease
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Course of disease
Code List
Status of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Drug related liver disease condition
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
C0699749 (UMLS CUI [1,3])
Course of disease
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Other liver disease condition
C3843040 (UMLS CUI-1)
C0023895 (UMLS CUI-2)
Specific condition
Item
Other Liver disease condition, specific condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Sequence Number
Item
Sequence Number
integer
C2348184 (UMLS CUI [1])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
boolean
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
boolean
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status of other liver disease
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Status of other liver disease
Code List
Status of other liver disease
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical condition
C3843040 (UMLS CUI-1)
Item
Other medical condition
integer
C3843040 (UMLS CUI [1])
Other medical condition
Code List
Other medical condition
CL Item
Drug Allergies (1)
CL Item
Rheumatoid Arthritis (2)
CL Item
Psoriasis (3)
CL Item
Thyroid Disease (4)
CL Item
Inflammatory Bowel Disease (5)
CL Item
Lupus (6)
CL Item
Sjogren's Syndrome (7)
CL Item
Vitiligo (8)
Item
Status of disease
integer
C0699749 (UMLS CUI [1])
Course of disease
Code List
Status of disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake (Liver alcohol)
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
Does the subject consume alcohol?
text
C0001948 (UMLS CUI [1])
Age
Code List
Does the subject consume alcohol?
CL Item
Yes (Y)
CL Item
No (N)
Average alcohol consumption
Item
Average number of units of alcohol consumed per week
float
C0560579 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
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