ID

38930

Description

Study ID: 111364 Clinical Study ID: 111364 Study Title: A 28-Day, Polysomnographic and subjective assessment of Vestipitant (15mg/day) for the treatment of Primary Insomnia in adult Outpatients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00992160 Clinicaltrials.gov Links: https://clinicaltrials.gov/ct2/show/NCT00992160 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Vestipitant, Placebo Trade Name: N/A Study Indication: Primary Insomnia, Sleep Disorders This phase II, placebo-controlled, double-blind trial studies the polysomnographic and subjective effect of the neurokinin (NK1) antagonist vestipitant (15mg/day at bedtime) for the treatment of primary insomnia in adult outpatients over a period of four weeks. The study consists of a clinical Screening Visit (Visit 1), up to 21 days before investigational product/placebo initiation, two screening polysomnographies (Visits 2 and 3), followed by a placebo run-in until Visit 4, at which the subject is randomized to vestipitant or placebo, taken every night for 28 days. On Day 1 and 2 (Visits 4 and 5), polysomnographies are performed. Visit 6 is a safety visit on Day 15. On Day 27 and 28, Visits 7 and 8 are performed, which again include polysomnography studies. Subjects then undergo a 7 to 10 day placebo run-out period and have Day 7 and Day 14 Follow-Up Visit (Visits 9 and 10). This form contains general information on any Liver Event happening during the study, including whether and when a pharmacokinetic sample has been obtained as well as information on the subject's general and liver-related medical conditions and alcohol intake. There are seperate forms for Imaging and Biopsy in case of a Liver Event.

Link

https://clinicaltrials.gov/ct2/show/NCT00992160

Keywords

Versions (1)
  1. 11/14/19 11/14/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 14, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Polysomnographic Assessment of Vestipitant for the Treatment of Primary Insomnia NCT00992160

English

Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site
Description

Study site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/Assessment
Description

Adverse Events/Concomitant Medications: Record details of any new serious adverse event or any changes to ongoing serious adverse events in the SAE form in the Logs/Rpts visit. » From visit 2 onwards, record details of any new non-serious adverse event or any changes to ongoing non-serious adverse events in the appropriate AE form in the Logs/Rpts visit » Record any changes to the subject's concomitant medication or any new medication taken since the last visit in the Con Meds form in the Logs/Rpts visit.

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
Description

Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0008000
UMLS CUI-3
C0304229
UMLS CUI-4
C2746065
UMLS CUI-5
C0243161
ALT (alanine aminotransferase)
Description

It is particularly important to record any significant hypotension immediately prior to or concomitant with ALT elevation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
AST (aspartate aminotransferase)
Description

AST reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Total bilirubin
Description

Total bilirubin reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Alkaline phosphatase
Description

Alkaline phosphatase reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
5' nucleotidase
Description

5' nucleotidase reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0202148
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Gammaglutamyltranspeptidase
Description

Gammaglutamyltranspeptidase reached stopping criteria

Data type

boolean

Alias
UMLS CUI [1,1]
C0202035
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0243161
Other
Description

Other liver chemistry result reached stopping criteria

Data type

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
Description

Liver Events - Clinical

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

Age

Data type

boolean

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

If yes, 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 Yes, answer whether the results were normal

Data type

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
If Yes, were the results normal?
Description

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

Data type

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?
Description

If yes, complete Liver Biopsy form.

Data type

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?
Description

If yes, record on the appropriate Concomitant Medication form.

Data type

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?
Description

Recent fasting or significant dietary change

Data type

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
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C2826267
Investigational Product (Liver)
Description

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
When did the liver event occur?
Description

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. Fill in entire itemgroup for both options, chosing "Not applicable" for the dates not required.

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0439564
UMLS CUI [1,5]
C2347804
Start Date Investigational Product not applicable
Description

If applicable, record date below.

Data type

boolean

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

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.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
End Date Investigational Product not applicable
Description

If applicable, record date below.

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [1,3]
C1272460
End Date Investigational Product
Description

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.

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
Pharmacokinetics
Description

Pharmacokinetics

Alias
UMLS CUI-1
C0005834
UMLS CUI-2
C0031328
UMLS CUI-3
C0023884
Was a pharmacokinetic blood sample obtained?
Description

An unscheduled PK sample must be obtained within 24-36 hours of last dose. If yes, record date and time sample taken, date and time of last investigational product dose prior to PK sample, and Sample Identifier

Data type

boolean

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

if applicable

Data type

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
Description

if applicable

Data type

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/Sample Number
Description

if applicable

Data type

text

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

Liver disease medical conditions

Alias
UMLS CUI-1
C0023895
Acute Viral Hepatitis A
Description

Acute type A viral hepatitis

Data type

text

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Hepatitis B, Chronic

Data type

text

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Hepatitis C, Chronic

Data type

text

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

text

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

Infectious Mononucleosis

Data type

text

Alias
UMLS CUI [1]
C0021345
Herpes Simplex Hepatitis
Description

Herpes Simplex Hepatitis

Data type

text

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Description

Alcoholic Liver Diseases

Data type

text

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

Non-alcoholic Steatohepatitis

Data type

text

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Description

Fatty Liver

Data type

text

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Description

Hepatic Cirrhosis

Data type

text

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

text

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

text

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Description

It is particularly important to record any gallbladder or biliary disease, or pancreatitis, that occurred during the study.

Data type

text

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

Drug related liver disease conditions

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

Drug related liver disease

Data type

text

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

Other Liver Disease

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Sequence Number
Description

Sequence Number

Data type

text

Alias
UMLS CUI [1]
C2348184
Specific Condition
Description

Other liver disease

Data type

text

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

Modified Term

Data type

text

Alias
UMLS CUI [1]
C2826302
MedDRA Synonym
Description

[hidden]

Data type

text

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

[hidden]

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Status
Description

Other Liver Disease Conditions - Status

Data type

text

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

Other medical conditions

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

Drug Allergies

Data type

text

Alias
UMLS CUI [1]
C0013182
Rheumatoid Arthritis
Description

Rheumatoid Arthritis

Data type

text

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

text

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Disease

Data type

text

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

text

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus

Data type

text

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

Sjogren's Syndrome

Data type

text

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

text

Alias
UMLS CUI [1]
C0042900
Alcohol Intake
Description

Alcohol Intake

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C0023884
UMLS CUI-3
C0877248
Does the subject consume alcohol?
Description

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

Data type

boolean

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

if applicable

Data type

float

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

[hidden]

Data type

text

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

Liver Events incl. Pharmacokinetics, Medical Conditions, Alcohol

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption criteria?
C0023884 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C2746065 (UMLS CUI-4)
C0243161 (UMLS CUI-5)
ALT reached stopping criteria
Item
ALT (alanine aminotransferase)
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
AST (aspartate aminotransferase)
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
Total bilirubin
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
Alkaline phosphatase
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
5' nucleotidase
boolean
C0202148 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
Gammaglutamyltranspeptidase reached stopping criteria
Item
Gammaglutamyltranspeptidase
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
Other
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 (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
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
If Yes, were the results 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
text
C2826267 (UMLS CUI [1])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Item
When did the liver event occur?
text
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0439564 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
undefined item
Code List
When did the liver event occur?
CL Item
During treatment period (During treatment period)
CL Item
After treatment period (After treatment period)
Start Date Investigational Product not applicable
Item
Start Date Investigational Product not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Start Date Investigational Product
Item
Start Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Investigational Product not applicable
Item
End Date Investigational Product not applicable
boolean
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
End Date Investigational Product
Item
End Date Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Pharmacokinetics
C0005834 (UMLS CUI-1)
C0031328 (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/Sample Number
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
text
C0276434 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Acute Viral Hepatitis A
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis B
text
C0524909 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis B
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Chronic Hepatitis C
text
C0524910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Chronic Hepatitis C
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Cytomegalovirus Hepatitis
text
C0276252 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Epstein Barr Virus Infectious Mononucleosis
text
C0021345 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Herpes Simplex Hepatitis
text
C1963747 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Alcoholic Liver Disease
text
C0023896 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Alcoholic Liver Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Non-alcoholic Steatohepatitis
text
C3241937 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Fatty Liver
text
C0015695 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Fatty Liver
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Hepatic Cirrhosis
text
C0023890 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hepatic Cirrhosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Hemochromatosis
text
C0018995 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Hemochromatosis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Autoimmune Hepatitis
text
C0241910 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Gallbladder disease
text
C0016977 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Gallbladder disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Drug related liver disease conditions
C0023895 (UMLS CUI-1)
C0041755 (UMLS CUI-2)
Item
Drug related liver disease
text
C0023895 (UMLS CUI [1,1])
C0041755 (UMLS CUI [1,2])
Acute type A viral hepatitis
Code List
Drug related liver disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Other Liver Disease
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Other liver disease
Item
Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Modified Term
Item
Modified Term
text
C2826302 (UMLS CUI [1])
MedDRA Synonym
Item
MedDRA Synonym
text
C1140263 (UMLS CUI [1,1])
C0871468 (UMLS CUI [1,2])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
text
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Item
Status
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
Liver diseases; Other, Status
Code List
Status
CL Item
Current (Current)
CL Item
Past (Past)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Drug Allergies
text
C0013182 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Drug Allergies
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Rheumatoid Arthritis
text
C0003873 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Rheumatoid Arthritis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Psoriasis
text
C0033860 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Psoriasis
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Thyroid Disease
text
C0040128 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Thyroid Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Inflammatory Bowel Disease
text
C0021390 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Inflammatory Bowel Disease
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Lupus
text
C0409974 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Lupus
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Sjogren's Syndrome
text
C1527336 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Sjogren's Syndrome
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item
Vitiligo
text
C0042900 (UMLS CUI [1])
Acute type A viral hepatitis
Code List
Vitiligo
CL Item
Current (Current)
CL Item
Past (Past)
CL Item
No Medical Condition (No Medical Condition)
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Alcohol consumption?
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
text
C0038586 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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