ID

32411

Beschreibung

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Stichworte

Versionen (1)
  1. 31.10.18 31.10.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

31. Oktober 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

Englisch

Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy

1 Formulare  
PGx- Pharmacogenetic Research Consent
Beschreibung

PGx- Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C2347500
Has informed consent been obtained for PGx- Pharmacogenetic research?
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
If informed consent has been contained, record Date informed consent obtained for PGx- Pharmacogenetic research.
Beschreibung

Date informed consent obtained

Datentyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0011008
If informed consent has been contained, has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
Beschreibung

Has a blood sample been collected for PGx- pharmacogenetic (DNA) research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0031325
UMLS CUI [2,3]
C0035168
If a blood sample has been collected for PGx- pharmacogenetic research, record date sample taken.
Beschreibung

Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C0035168
UMLS CUI [1,3]
C1302413
If informed consent has not been obtained, check reason.
Beschreibung

Reason for informed consent has not been obtained

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0566251
If other reason for informed consent not been obtained, specify.
Beschreibung

Other reason for informed consent not been obtained

Datentyp

text

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2347500
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Pharmacogenetic (PGx) Research withdrawal of consent
Beschreibung

Pharmacogenetic (PGx) Research withdrawal of consent

Alias
UMLS CUI-1
C0031325
UMLS CUI-2
C1707492
Has subject withdrawn consent for PGx research?
Beschreibung

Has subject withdrawn consent for PGx research?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C1707492
If subject has withdrawn consent, record date.
Beschreibung

Date informed consent withdrawn

Datentyp

date

Alias
UMLS CUI [1,1]
C0031325
UMLS CUI [1,2]
C1707492
UMLS CUI [1,3]
C0011008
Has a request been made for sample destruction?
Beschreibung

Has a request been made for sample destruction?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
If a request has been made for sample destruction, check reason.
Beschreibung

Reason for request for sample destruction

Datentyp

integer

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [1,4]
C0566251
If other reason for request for sample destruction, specify.
Beschreibung

Other reason for request for sample destruction

Datentyp

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Liver Events
Beschreibung

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Is this liver event a serious adverse event?
Beschreibung

Is this liver event a serious adverse event?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C1519255
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
Beschreibung

Liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria

Datentyp

integer

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0587081
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C2133636
Is the subject age 55 or older?
Beschreibung

Is the subject age 55 or older?

Datentyp

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Datentyp

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 reasonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
Beschreibung

Diagnostic imaging tests of the liver or hepatobiliary system

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
UMLS CUI [2]
C0412534
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0412620
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0008310
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
Beschreibung

If No, record the details on the Imaging form. Please ensure the overall diagnosis indicated by imaging is captured on the Non- serious Adverse Event form or serious Adverse Event form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C1274040
Were any liver biopsies performed?
Beschreibung

If yes, complete Liver Biopsy form.

Datentyp

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Datentyp

boolean

Alias
UMLS CUI [1]
C1504473
UMLS CUI [2]
C0002346
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Beschreibung

Did the subject fast or undergo significant change in the past week?

Datentyp

boolean

Alias
UMLS CUI [1]
C0015663
UMLS CUI [2,1]
C3671772
UMLS CUI [2,2]
C0750502
Investigational Product (Liver)
Beschreibung

Investigational Product (Liver)

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

When did the liver event occur?

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
If the liver event occured during treatment period record start date of investigational product for that treatment period.
Beschreibung

If liver event occured after treatment period, start date of investigational product

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0808070
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1948053
If the liver event occured during treatment period record stop date of investigational product for that treatment period.
Beschreibung

If liver event occured during treatment period, stop date of investigational product

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0806020
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1948053
If the liver event occured after treatment period record start date of investigational product for the most recent period prior to the liver event.
Beschreibung

If liver event occured after treatment period, start date of investigational product

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0808070
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1948053
If the liver event occured after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Beschreibung

If liver event occured after treatment period, stop date of investigational product

Datentyp

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2745955
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0806020
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1948053
Pharmacokinetics (Liver)
Beschreibung

Pharmacokinetics (Liver)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0023884
Was a pharmacokinetic blood sample obtained?
Beschreibung

Was a pharmacokinetic blood sample obtained?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If a pharmacokinetic blood sample was obtained, record date and time sample taken.
Beschreibung

Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C1264639
If pharmacokinetic blood sample was obtained, record date and time of last investigational product dose prior to PK sample.
Beschreibung

Date and time of last investigational product dose prior to PK sample

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0946444
If pharmacokinetic blood sample was obtained, record date and time of last Ketoconazole dose prior to PK sample.
Beschreibung

Date and time of last Ketoconazole dose

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C1762893
UMLS CUI [1,3]
C0946444
Medical conditions at onset of liver event
Beschreibung

Medical conditions at onset of liver event

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
Acute Viral Hepatitis A
Beschreibung

Acute Viral Hepatitis A

Datentyp

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Beschreibung

Chronic Hepatitis B

Datentyp

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Beschreibung

Chronic Hepatitis C

Datentyp

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Beschreibung

Cytomegalovirus Hepatitis

Datentyp

integer

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

Epstein Barr Virus Infectious Mononucleosis

Datentyp

integer

Alias
UMLS CUI [1,1]
C0021345
UMLS CUI [1,2]
C0014644
Herpes Simplex Hepatitis
Beschreibung

Herpes Simplex Hepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Beschreibung

Alcoholic Liver Disease

Datentyp

integer

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

Non- alcoholic Steatohepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Beschreibung

Fatty Liver

Datentyp

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Beschreibung

Hepatic Cirrhosis

Datentyp

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Beschreibung

Hemochromatosis

Datentyp

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Beschreibung

Autoimmune Hepatitis

Datentyp

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease
Beschreibung

Gallbladder disease

Datentyp

integer

Alias
UMLS CUI [1]
C0016977
Drug related liver disease
Beschreibung

Drug related liver disease

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other Liver Disease Conditions
Beschreibung

Other Liver Disease Conditions

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

Sequence Number

Datentyp

text

Alias
UMLS CUI [1]
C2348184
Specific Condition
Beschreibung

Specific Condition

Datentyp

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Status of liver disease condition
Beschreibung

Status of liver disease condition

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0449438
Other medical conditions
Beschreibung

Other medical conditions

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

Drug Allergies

Datentyp

integer

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
Rheumatoid Arthritis
Beschreibung

Rheumatoid Arthritis

Datentyp

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Beschreibung

Psoriasis

Datentyp

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Beschreibung

Thyroid Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Beschreibung

Inflammatory Bowel Disease

Datentyp

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Beschreibung

Lupus

Datentyp

integer

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

Sjogren's Syndrome

Datentyp

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Beschreibung

Vitiligo

Datentyp

integer

Alias
UMLS CUI [1]
C0042900
Alcohol intake at onset of liver event
Beschreibung

Alcohol intake at onset of liver event

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C0023884
UMLS CUI-3
C0877248
UMLS CUI-4
C0332162
Does the subject consume alcohol?
Beschreibung

Does the subject consume alcohol?

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
If subject consumes alcohol, record the average number of units of alcohol consumed per week.
Beschreibung

Average number of units of alcohol consumed per week

Datentyp

integer

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Liver imaging
Beschreibung

Liver imaging

Alias
UMLS CUI-1
C2711860
Date of hepatic or liver imaging test.
Beschreibung

Date of hepatic or liver imaging tes

Datentyp

date

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C0011008
What method was used for this imaging test?
Beschreibung

Method used for this imaging test

Datentyp

integer

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
If other method was used for imaging test, specify.
Beschreibung

Other method used for imaging test

Datentyp

text

Alias
UMLS CUI [1,1]
C2711860
UMLS CUI [1,2]
C1275506
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Are images technically adequate?
Beschreibung

Are images technically adequate?

Datentyp

integer

Alias
UMLS CUI [1]
C0806487
If other image quality, specify.
Beschreibung

Other image quality

Datentyp

text

Alias
UMLS CUI [1,1]
C0806487
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver size
Beschreibung

Indicate the liver size

Datentyp

integer

Alias
UMLS CUI [1]
C0426688
If other liver size, specify.
Beschreibung

Other liver size

Datentyp

text

Alias
UMLS CUI [1,1]
C0426688
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Indicate the liver texture.
Beschreibung

Indicate the liver texture.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
If other liver texture, specify.
Beschreibung

Other liver texture

Datentyp

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0205394
Grade the diffuse and/ or geographic fatty infiltrate of the liver
Beschreibung

Grade the diffuse and/ or geographic fatty infiltrate of the liver

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
If other fatty infiltrate of the liver, specify.
Beschreibung

Other fatty infiltrate of the liver

Datentyp

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Ascites present
Beschreibung

Ascites present

Datentyp

integer

Alias
UMLS CUI [1]
C0003962
If other ascites, specify.
Beschreibung

Other ascites

Datentyp

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Are focal hepatic lesions characterisable?
Beschreibung

Focal hepatic lesions

Datentyp

integer

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If other focal hepatic lesions, specify.
Beschreibung

Other focal hepatic lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Gallstones or gallbladder lesions?
Beschreibung

Gallstones or gallbladder lesions?

Datentyp

integer

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If other gallstones or gallbladder lesions, specify.
Beschreibung

Other gallstones or gallbladder lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Biliary ductal lesions?
Beschreibung

Biliary ductal lesions?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If other biliary ductal lesions, specify.
Beschreibung

Other biliary ductal lesions

Datentyp

text

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0205394
Portal/ Hepatic vein abnormalities?
Beschreibung

Portal/ Hepatic vein abnormalities?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
If other portal/ hepatic vein abnormalities, specify.
Beschreibung

Other portal/ hepatic vein abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0032718
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235
Liver biopsy
Beschreibung

Liver biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Beschreibung

Date of liver biopsy

Datentyp

date

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0011008
Approximate size of liver biopsy
Beschreibung

Approximate size of liver biopsy

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Final Diagnosis
Beschreibung

Final Diagnosis

Datentyp

integer

Alias
UMLS CUI [1]
C1546485
If other final diagnosis, specify.
Beschreibung

Other final diagnosis

Datentyp

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver Architecture
Beschreibung

Liver Architecture

Datentyp

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
If other liver architecture, specify.
Beschreibung

Other liver architecture.

Datentyp

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Description of liver cells or hepatocytes
Beschreibung

Description of liver cells or hepatocytes

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
If other description of liver cells or hepatocytes, specify.
Beschreibung

Other description of liver cells or hepatocytes

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Liver cell or hepatocyte inclusions or vacuoles
Beschreibung

Liver cell or hepatocyte inclusions or vacuoles

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
If other liver cell or hepatocyte inclusions or vacuoles, specify.
Beschreibung

Other liver cell or hepatocyte inclusions or vacuoles

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0042219
UMLS CUI [1,3]
C1512693
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Hepatocyte or liver cell nuclear abnormalities.
Beschreibung

Hepatocyte or liver cell nuclear abnormalities.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
If other hepatocyte or liver cell nuclear abnormalities, specify.
Beschreibung

Other hepatocyte or liver cell nuclear abnormalities

Datentyp

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Liver or lobular infiltrates
Beschreibung

Liver or lobular infiltrates

Datentyp

integer

Alias
UMLS CUI [1,1]
C1400896
UMLS CUI [1,2]
C0205417
If other liver or lobular infiltrates, specify.
Beschreibung

Other liver or lobular infiltrates

Datentyp

text

Alias
UMLS CUI [1,1]
C1400896
UMLS CUI [1,2]
C0205417
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Portal tract inflammation
Beschreibung

Portal tract inflammation

Datentyp

integer

Alias
UMLS CUI [1]
C3854488
If other portal tract inflammation, specify.
Beschreibung

Other portal tract inflammation

Datentyp

text

Alias
UMLS CUI [1,1]
C3854488
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Bile ducts
Beschreibung

Bile ducts

Datentyp

integer

Alias
UMLS CUI [1]
C0005400
If other bile ducts, specify.
Beschreibung

Other bile ducts

Datentyp

text

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Portal veins
Beschreibung

Portal veins

Datentyp

integer

Alias
UMLS CUI [1]
C0032718
If other portal vein structure, specify.
Beschreibung

Other portal vein structure

Datentyp

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver infections
Beschreibung

Liver infections

Datentyp

integer

Alias
UMLS CUI [1]
C1112211
If other liver infections, specify.
Beschreibung

Other liver infections

Datentyp

text

Alias
UMLS CUI [1,1]
C1112211
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Parasites or Ova
Beschreibung

Parasites or Ova

Datentyp

integer

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0555117
If other parasites or ova, specify.
Beschreibung

Other parasites or ova

Datentyp

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0555117
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Histologic staining or additional studies obtained
Beschreibung

Histologic staining or additional studies obtained

Datentyp

integer

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C1524062
If other histologic staining or additional studies obtained,l specify.
Beschreibung

Other histologic staining or additional studies

Datentyp

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0205462
UMLS CUI [2,1]
C2603343
UMLS CUI [2,2]
C1524062
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
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Ähnliche Modelle

Pharmacogenetic Research Consent, Pharmacogenetic Research Withdrawal of Consent, Liver Events, Pharmacokinetics, Medical Conditions at Onset of Liver Event, Alcohol Intake, Liver Imaging, Liver Biopsy

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
PGx- Pharmacogenetic Research Consent
C0021430 (UMLS CUI-1)
C2347500 (UMLS CUI-2)
Informed consent
Item
Has informed consent been obtained for PGx- Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
Date informed consent obtained
Item
If informed consent has been contained, record Date informed consent obtained for PGx- Pharmacogenetic research.
date
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
Item
If informed consent has been contained, has a blood sample been collected for PGx- pharmacogenetic (DNA) research?
boolean
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0031325 (UMLS CUI [2,2])
C0035168 (UMLS CUI [2,3])
Date sample taken
Item
If a blood sample has been collected for PGx- pharmacogenetic research, record date sample taken.
date
C0031325 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Item
If informed consent has not been obtained, check reason.
integer
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
undefined item
Code List
If informed consent has not been obtained, check reason.
CL Item
Subject declined (1)
CL Item
Subject not asked by investigator (2)
CL Item
Other, specify (3)
Other reason for informed consent not been obtained
Item
If other reason for informed consent not been obtained, specify.
text
C0021430 (UMLS CUI [1,1])
C2347500 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Pharmacogenetic (PGx) Research withdrawal of consent
C0031325 (UMLS CUI-1)
C1707492 (UMLS CUI-2)
Has subject withdrawn consent for PGx research?
Item
Has subject withdrawn consent for PGx research?
boolean
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
Date informed consent withdrawn
Item
If subject has withdrawn consent, record date.
date
C0031325 (UMLS CUI [1,1])
C1707492 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Item
If a request has been made for sample destruction, check reason.
integer
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
Reason for request for sample destruction
Code List
If a request has been made for sample destruction, check reason.
CL Item
Subject withdrew consent for PGx (3)
CL Item
Screen failure (2)
CL Item
Other, specify (1)
Other reason for request for sample destruction
Item
If other reason for request for sample destruction, specify.
text
C1272683 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Is this liver event a serious adverse event?
Item
Is this liver event a serious adverse event?
boolean
C0023884 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
integer
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2133636 (UMLS CUI [2,2])
Liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria
Code List
Which liver chemistry result reached or exceeded protocol- defined investigational product stopping/ interruption criteria?
CL Item
ALT (alanine aminotansferase) (1)
CL Item
AST (aspartate aminotransferase) (2)
CL Item
Total bilirubin (3)
CL Item
Alkaline phosphatase (4)
CL Item
5' nucleotidase (5)
CL Item
Gammaglutamyltranspeptidase (6)
CL Item
Other (7)
Is the subject age 55 or older?
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])
If female, is the subject pregnant?
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Diagnostic imaging tests of the liver or hepatobiliary system
Item
Were any diagnostic imaging tests of the liver or hepatobiliary system performed (such as liver ultrasound, computerised tomography or CAT scan, magnetic reasonance imaging or MRI, or endoscopic retrograde cholangiopancreatography, or other)?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0412534 (UMLS CUI [2])
C0040405 (UMLS CUI [3])
C0412620 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
Diagnostic imaging tests of the liver or hepatobiliary system results
Item
If any diagnostic imaging tests of the liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Liver biopsies
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs
Item
Does the subject use herbals, complementary or alternative medicines, food supplements (vitamins) or illicit drugs?
boolean
C1504473 (UMLS CUI [1])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0281875 (UMLS CUI [4])
Did the subject fast or undergo significant change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
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])
When did the liver event occur?
Code List
When did the liver event occur?
CL Item
During the treatment period: If the liver event occured during treatment period record start and stop date of investigational product for that treatment period. (D)
CL Item
After the treatment period: If the liver event occured after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. (A)
If liver event occured after treatment period, start date of investigational product
Item
If the liver event occured during treatment period record start date of investigational product for that treatment period.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured during treatment period, stop date of investigational product
Item
If the liver event occured during treatment period record stop date of investigational product for that treatment period.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured after treatment period, start date of investigational product
Item
If the liver event occured after treatment period record start date of investigational product for the most recent period prior to the liver event.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0808070 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
If liver event occured after treatment period, stop date of investigational product
Item
If the liver event occured after treatment period record stop date of investigational product for the most recent period prior to the liver event.
date
C0877248 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0806020 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C1948053 (UMLS CUI [3,2])
Item Group
Pharmacokinetics (Liver)
C0031327 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
Was a pharmacokinetic blood sample obtained?
Item
Was a pharmacokinetic blood sample obtained?
boolean
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Date and time sample taken
Item
If a pharmacokinetic blood sample was obtained, record date and time sample taken.
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Date and time of last investigational product dose prior to PK sample
Item
If pharmacokinetic blood sample was obtained, record date and time of last investigational product dose prior to PK sample.
datetime
C0304229 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Date and time of last Ketoconazole dose
Item
If pharmacokinetic blood sample was obtained, record date and time of last Ketoconazole dose prior to PK sample.
datetime
C0022625 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,3])
Item Group
Medical conditions at onset of liver event
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
Item
Acute Viral Hepatitis A
integer
C0276434 (UMLS CUI [1])
Acute Viral Hepatitis A
Code List
Acute Viral Hepatitis A
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis B
integer
C0524909 (UMLS CUI [1])
Chronic Hepatitis B
Code List
Chronic Hepatitis B
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Chronic Hepatitis C
integer
C0524910 (UMLS CUI [1])
Chronic Hepatitis C
Code List
Chronic Hepatitis C
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Cytomegalovirus Hepatitis
integer
C0276252 (UMLS CUI [1])
Cytomegalovirus Hepatitis
Code List
Cytomegalovirus Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Epstein Barr Virus Infectious Mononucleosis
integer
C0021345 (UMLS CUI [1,1])
C0014644 (UMLS CUI [1,2])
Epstein Barr Virus Infectious Mononucleosis
Code List
Epstein Barr Virus Infectious Mononucleosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Herpes Simplex Hepatitis
integer
C1963747 (UMLS CUI [1])
Herpes Simplex Hepatitis
Code List
Herpes Simplex Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
Alcoholic Liver Disease
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Non- alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Non- alcoholic Steatohepatitis
Code List
Non- alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Fatty Liver
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Hepatic Cirrhosis
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Hemochromatosis
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Autoimmune Hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Gallbladder disease
integer
C0016977 (UMLS CUI [1])
Gallbladder disease
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Drug related liver 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 Conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Status of liver disease condition
integer
C0023895 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Status of liver disease condition
Code List
Status of liver disease condition
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
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Drug Allergies
Code List
Drug Allergies
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Rheumatoid Arthritis
integer
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis
Code List
Rheumatoid Arthritis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Psoriasis
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Thyroid Disease
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Inflammatory Bowel Disease
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Lupus
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Sjogren's Syndrome
Code List
Sjogren's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Vitiligo
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Alcohol intake at onset of liver event
C0001948 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0332162 (UMLS CUI-4)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
Average number of units of alcohol consumed per week
Item
If subject consumes alcohol, record the average number of units of alcohol consumed per week.
integer
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Liver imaging
C2711860 (UMLS CUI-1)
Date of hepatic or liver imaging tes
Item
Date of hepatic or liver imaging test.
date
C2711860 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
What method was used for this imaging test?
integer
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
Method used for this imaging test
Code List
What method was used for this imaging test?
CL Item
Ultrasound - transabdominal (1)
CL Item
Ultrasound - endoscopic (2)
CL Item
Magnetic Resonance Imaging (MRI) (3)
CL Item
Computerised Tomography (CT) (4)
CL Item
Endoscopic Retrograde Cholangiopancreatography (ERCP) (5)
CL Item
Positron Emission Tomography (PET) (6)
CL Item
Positron Emission Tomography/ Computerised Tomography (PET/ CT) (7)
CL Item
Other, specify (8)
Other method used for imaging test
Item
If other method was used for imaging test, specify.
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Are images technically adequate?
integer
C0806487 (UMLS CUI [1])
Are images technically adequate?
Code List
Are images technically adequate?
CL Item
Optimal (1)
CL Item
Readable, but not optimal (2)
CL Item
Not readable (3)
CL Item
Other, specify (4)
Other image quality
Item
If other image quality, specify.
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver size
integer
C0426688 (UMLS CUI [1])
Indicate the liver size
Code List
Indicate the liver size
CL Item
Normal size (1)
CL Item
Hypertrophy (or enlarged) (2)
CL Item
Atrophy (or smaller than normal) (3)
CL Item
Segmental hypertrophy (4)
CL Item
Other, specify (5)
Other liver size
Item
If other liver size, specify.
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture.
integer
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Indicate the liver texture.
Code List
Indicate the liver texture.
CL Item
Normal (1)
CL Item
Heterogeneous (2)
CL Item
Suggestive of fibrosis (3)
CL Item
Nodular or suggestive of cirrhosis (4)
CL Item
Other, specify (5)
Other liver texture
Item
If other liver texture, specify.
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Grade the diffuse and/ or geographic fatty infiltrate of the liver
integer
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
Grade the diffuse and/ or geographic fatty infiltrate of the liver
Code List
Grade the diffuse and/ or geographic fatty infiltrate of the liver
CL Item
Not applicable - no fatty infiltration (1)
CL Item
Mild (<= 25%) (2)
CL Item
Moderate (>25% to <75%) (3)
CL Item
Severe (>= 75%) (4)
CL Item
Other, specify (5)
Other fatty infiltrate of the liver
Item
If other fatty infiltrate of the liver, specify.
text
C0015695 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Ascites present
integer
C0003962 (UMLS CUI [1])
Ascites present
Code List
Ascites present
CL Item
Non present (1)
CL Item
Yes - small amount (2)
CL Item
Yes - moderate or severe amount (3)
CL Item
Other, specify (99)
Other ascites
Item
If other ascites, specify.
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Are focal hepatic lesions characterisable?
integer
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Focal hepatic lesions
Code List
Are focal hepatic lesions characterisable?
CL Item
Not applicable (1)
CL Item
Solid (2)
CL Item
Cystic (3)
CL Item
Hemangioma (4)
CL Item
Focal Nodular Hyperplasia (5)
CL Item
Other, specify (6)
Other focal hepatic lesions
Item
If other focal hepatic lesions, specify.
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Gallstones or gallbladder lesions?
integer
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Gallstones or gallbladder lesions?
Code List
Gallstones or gallbladder lesions?
CL Item
None (1)
CL Item
Gallstones (2)
CL Item
Gallbladder polyp(s) (3)
CL Item
Sludge (4)
CL Item
Gallbladder wall thickening/ oedema (5)
CL Item
Gallbladder wall gas (6)
CL Item
Cholecystitis (7)
CL Item
Gallbladder wall calcification (8)
CL Item
Gallbladder mass (9)
CL Item
Other, specify (10)
Other gallstones or gallbladder lesions
Item
If other gallstones or gallbladder lesions, specify.
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Biliary ductal lesions?
integer
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Biliary ductal lesions?
Code List
Biliary ductal lesions?
CL Item
None (1)
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (2)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (3)
CL Item
Intrahepatic ductal dilation (involving both right and left hepatic lobes) (4)
CL Item
Extrahepatic ductal dilation (5)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ductus) (6)
CL Item
Acute Cholangitis (7)
CL Item
Primary sclerosing cholangitis (8)
CL Item
Choledocholithiasis (gallstone in duct) (9)
CL Item
Ducta filling defect(s), other than gallstone (10)
CL Item
Ductal wall thickening or oedema (11)
CL Item
Choledochal cyst (12)
CL Item
Ductal mass (13)
CL Item
Extrinsic mass compressing bile duct(s) (14)
CL Item
Other, specify (15)
Other biliary ductal lesions
Item
If other biliary ductal lesions, specify.
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Item
Portal/ Hepatic vein abnormalities?
integer
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
Portal/ Hepatic vein abnormalities?
Code List
Portal/ Hepatic vein abnormalities?
CL Item
None (1)
CL Item
Portal vein enlargement (2)
CL Item
Hepatic vein enlargement (3)
CL Item
Non- occlusive portal vein thrombosis (4)
CL Item
Occlusvie portal vein thrombosis - bland (5)
CL Item
Hepatic vein thrombosis - bland (6)
CL Item
Occlusive portal vein thrombosis - malignant (7)
CL Item
Hepatic vein thrombosis - malignant (8)
CL Item
Involvement of the main portal vein (9)
CL Item
Involvement of the right portal vein (10)
CL Item
involvement of the left portal vein (11)
CL Item
Budd- Chiari syndrome (12)
CL Item
Other, specify (13)
Other portal/ hepatic vein abnormalities
Item
If other portal/ hepatic vein abnormalities, specify.
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0032718 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item Group
Liver biopsy
C0193388 (UMLS CUI-1)
Date of liver biopsy
Item
Date of liver biopsy
date
C0193388 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
float
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Item
Final Diagnosis
integer
C1546485 (UMLS CUI [1])
Final Diagnosis
Code List
Final Diagnosis
CL Item
Normal (1)
CL Item
Acute hepatitis (2)
CL Item
Chronic hepatitis (3)
CL Item
Cholestatic hepatitis (4)
CL Item
Drug- induced cholestais (5)
CL Item
Acute viral hepatitis (6)
CL Item
Chronic viral hepatitis (7)
CL Item
Drug- induced hepatitis (8)
CL Item
Autoimmune hepatitis (9)
CL Item
Bridging necrosis (10)
CL Item
Submassive hepatic necrosis (11)
CL Item
Massive hepatic necrosis (12)
CL Item
Steatosis - microvesicular (13)
CL Item
Steatosis - macrovesicular (14)
CL Item
Steatosis - mixed (15)
CL Item
Non- alcoholic steatohepatitis (16)
CL Item
Alcoholic hepatitis (17)
CL Item
Hepatic granulomas (18)
CL Item
Sarcoidosis (19)
CL Item
Fibrosis (20)
CL Item
Cirrhosis (21)
CL Item
Primary biliary cirrhosis (22)
CL Item
Primary sclerosing cholangitis (23)
CL Item
Autoimmune overlap syndrome (24)
CL Item
Hemochromatosis (25)
CL Item
Alpha-1- antitrypsin deficiency (26)
CL Item
Wilson's disease (27)
CL Item
Veno- occlusive disease (28)
CL Item
Budd- Chiari syndrome (29)
CL Item
Neoplasia (30)
CL Item
Other (31)
Other final diagnosis
Item
If other final diagnosis, specify.
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver Architecture
integer
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Liver Architecture
Code List
Liver Architecture
CL Item
Normal (1)
CL Item
Bridging fibrosis (2)
CL Item
Diffuse fibrosis (3)
CL Item
Nodular regenerative hyperplasia (4)
CL Item
Congenital hepatic fibrosis (5)
CL Item
Cirrhosis (6)
CL Item
Centrilobular congestion (7)
CL Item
Endophlebitis (8)
CL Item
Veno- occlusive disease (9)
CL Item
Canalicular cholestasis (10)
CL Item
Apoptosis (11)
CL Item
Focal (or spotty or mild) hepatocelular necrosis (12)
CL Item
Interface hepatitis (periportal hepatitis or pieceneal necrosis) (13)
CL Item
Ischaemic necrosis (14)
CL Item
Centrolobular (Zone 3) necrosis (15)
CL Item
Bridging hepatocellular necrosis (16)
CL Item
Massive or panlobular hepatocellular necrosis (17)
CL Item
Dysplasia (18)
CL Item
Neoplasia (19)
CL Item
Other (20)
Other liver architecture.
Item
If other liver architecture, specify.
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Description of liver cells or hepatocytes
integer
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Description of liver cells or hepatocytes
Code List
Description of liver cells or hepatocytes
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other, specify (6)
Other description of liver cells or hepatocytes
Item
If other description of liver cells or hepatocytes, specify.
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Liver cell or hepatocyte inclusions or vacuoles
integer
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Liver cell or hepatocyte inclusions or vacuoles
Code List
Liver cell or hepatocyte inclusions or vacuoles
CL Item
No inclusions (1)
CL Item
Macrovesicular steatosis (2)
CL Item
Microvesicular steatosis (3)
CL Item
Bile accumulation (4)
CL Item
Diastase- resistant, PAS- positive cytoplasmic inclusions (5)
CL Item
Alpha-1- antitrypsin inclusions (6)
CL Item
Megamitochondria (7)
CL Item
Mallory bodies (8)
CL Item
"Ground Glass" inclusions (9)
CL Item
Lipofuscin pigment (10)
CL Item
Hemosiderin granules (11)
CL Item
Orcein- positive cytoplasmin granules (12)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (13)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (14)
CL Item
Other, specify (15)
Other liver cell or hepatocyte inclusions or vacuoles
Item
If other liver cell or hepatocyte inclusions or vacuoles, specify.
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Hepatocyte or liver cell nuclear abnormalities.
integer
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
Hepatocyte or liver cell nuclear abnormalities.
Code List
Hepatocyte or liver cell nuclear abnormalities.
CL Item
None (1)
CL Item
Hepatocellular mitosis (2)
CL Item
Binucleated or multinucleated hepatocytes (3)
CL Item
CMV inclusion bodies (4)
CL Item
HSV inclusions (5)
CL Item
Varicella inclusions (6)
CL Item
Other, specify (7)
Other hepatocyte or liver cell nuclear abnormalities
Item
If other hepatocyte or liver cell nuclear abnormalities, specify.
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Liver or lobular infiltrates
integer
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
Liver or lobular infiltrates
Code List
Liver or lobular infiltrates
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphocytes (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer cells (6)
CL Item
Granulomas (7)
CL Item
Other, specify (8)
Other liver or lobular infiltrates
Item
If other liver or lobular infiltrates, specify.
text
C1400896 (UMLS CUI [1,1])
C0205417 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Portal tract inflammation
integer
C3854488 (UMLS CUI [1])
Portal tract inflammation
Code List
Portal tract inflammation
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/ or follicles (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other (7)
Other portal tract inflammation
Item
If other portal tract inflammation, specify.
text
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Bile ducts
integer
C0005400 (UMLS CUI [1])
Bile ducts
Code List
Bile ducts
CL Item
Normal (1)
CL Item
Proliferation of the bile ducts (bile ductular reaction) (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other, specify (6)
Other bile ducts
Item
If other bile ducts, specify.
text
C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Portal veins
integer
C0032718 (UMLS CUI [1])
Portal veins
Code List
Portal veins
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (3)
CL Item
Neoplastic invasion of portal vein (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
6 Other, specify (6)
Other portal vein structure
Item
If other portal vein structure, specify.
text
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver infections
integer
C1112211 (UMLS CUI [1])
Liver infections
Code List
Liver infections
CL Item
Normal (1)
CL Item
Leishmaniasis donovani (2)
CL Item
Plasmodium falciparum (3)
CL Item
Toxoplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Myobacterium tuberculosis (7)
CL Item
Other myobacterial species (8)
CL Item
Other, specify (9)
Other liver infections
Item
If other liver infections, specify.
text
C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Parasites or Ova
integer
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
Parasites or Ova
Code List
Parasites or Ova
CL Item
None (1)
CL Item
Schistosome and/ or ova (2)
CL Item
Ascaris and/ or ova (3)
CL Item
Toxocara and/ or ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic capillariasis worms and/ or ova (6)
CL Item
Other, specify (7)
Other parasites or ova
Item
If other parasites or ova, specify.
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item
Histologic staining or additional studies obtained
integer
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
Histologic staining or additional studies obtained
Code List
Histologic staining or additional studies obtained
CL Item
Haematoxylin and eosin (or H&E) (1)
CL Item
Masson (2)
CL Item
Toluidine blue or Giemsa (3)
CL Item
Prussian blue (4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (5)
CL Item
Oil red O (6)
CL Item
Congo red (7)
CL Item
Hall's stain (8)
CL Item
Gridley's stain (9)
CL Item
Rhodanine (copper) (10)
CL Item
Rubeanic acid (copper) (11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (12)
CL Item
Electron microscopy (13)
CL Item
Hepatitis A immunostains positive (14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (15)
CL Item
Hepatitis D immunostains (16)
CL Item
Other immunostains (17)
CL Item
Other, specify (18)
Other histologic staining or additional studies
Item
If other histologic staining or additional studies obtained,l specify.
text
C0487602 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
C2603343 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
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