ID

37498

Descrizione

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Keywords

versioni (2)
  1. 29/05/19 29/05/19 -
  2. 02/08/19 02/08/19 -
Titolare del copyright

GlaxoSmithKline

Caricato su

2 agosto 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
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Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328

Inglese

Liver Events; Investigational Product (Liver); Alcohol Intake (Liver Alcohol); Medical Conditions; Pharmacokinetics (Liver); Liver Biopsy; Liver Imaging

1 moduli  
Liver Events
Descrizione

Liver Events

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Descrizione

Check all that apply

Tipo di dati

text

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]
C2746065
UMLS CUI [2,3]
C0243161
Is the subject age 55 or older?
Descrizione

Is the subject age 55 or older?

Tipo di dati

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Tipo di dati

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)?
Descrizione

Were any diagnostic imaging tests of the liver or hepatobiliary system performed?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1711359
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C0023884
UMLS CUI [3,1]
C1456803
UMLS CUI [3,2]
C0023884
UMLS CUI [4]
C0040405
UMLS CUI [5]
C0436427
UMLS CUI [6]
C0024485
UMLS CUI [7]
C0008310
If diagnostic imaging tests of liver or hepatobiliary system were performed, were the results normal?
Descrizione

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

Tipo di dati

boolean

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

If yes, complete Liver Biopsy form.

Tipo di dati

boolean

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

If yes, record on the appropriate Concomitant Medication form.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1360419
UMLS CUI [2]
C0002346
UMLS CUI [3]
C0242295
UMLS CUI [4]
C0042890
UMLS CUI [5]
C0086190
Did the subject fast or undergo significant dietary change in the past week?
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3671772
UMLS CUI [1,2]
C2826293
Investigational Product (Liver)
Descrizione

Investigational Product (Liver)

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0023884
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
Descrizione

If the liver event occurred during treatment period record start date of investigational product for that treatment period.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0347984
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0808070
If the liver event occurred during treatment period record start date of investigational product for that treatment period - not applicable
Descrizione

If the liver event occurred during treatment period record start date of investigational product for that treatment period - not applicable

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0347984
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0808070
UMLS CUI [4]
C1272460
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
Descrizione

If the liver event occurred during treatment period record stop date of investigational product for that treatment period.

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0347984
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0806020
If the liver event occurred during treatment period record stop date of investigational product for that treatment period - not applicable
Descrizione

If the liver event occurred during treatment period record stop date of investigational product for that treatment period - not applicable

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0347984
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0806020
UMLS CUI [4]
C1272460
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
Descrizione

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

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0808070
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event - not applicable
Descrizione

If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event - not applicable

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0808070
UMLS CUI [4]
C1272460
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Descrizione

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

Tipo di dati

date

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0806020
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event - not applicable
Descrizione

If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event - not applicable

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0687676
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0806020
UMLS CUI [4]
C1272460
Alcohol intake
Descrizione

Alcohol intake

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

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001948C0001948
Average number of units of alcohol consumed per week
Descrizione

Average number of units of alcohol consumed per week

Tipo di dati

float

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
Medical Conditions (Liver)
Descrizione

Medical Conditions (Liver)

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0023884
Acute Viral Hepatitis A
Descrizione

Acute Viral Hepatitis A

Tipo di dati

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Descrizione

Chronic Hepatitis B

Tipo di dati

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Descrizione

Chronic Hepatitis C

Tipo di dati

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Descrizione

Cytomegalovirus Hepatitis

Tipo di dati

integer

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

Epstein Barr Virus Infectious Mononucleosis

Tipo di dati

integer

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

Herpes Simplex Hepatitis

Tipo di dati

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Descrizione

Alcoholic Liver Disease

Tipo di dati

integer

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

Non-alcoholic Steatohepatitis

Tipo di dati

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Descrizione

Fatty Liver

Tipo di dati

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Descrizione

Hepatic Cirrhosis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Descrizione

Hemochromatosis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Descrizione

Autoimmune Hepatitis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0241910
Gallbladder disease or biliary disease
Descrizione

Gallbladder disease or biliary disease

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0016977
UMLS CUI [1,2]
C3275124
Drug related liver disease conditions
Descrizione

Drug related liver disease conditions

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

Drug related liver disease

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Other liver disease conditions
Descrizione

Other liver disease conditions

Alias
UMLS CUI-1
C0023895
UMLS CUI-2
C0205394
Other liver disease conditions - Sequence Number
Descrizione

Other liver disease conditions - Sequence Number

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2348184
Other liver disease conditions - Specific Condition
Descrizione

Other liver disease conditions - Specific Condition

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348235
Other liver disease conditions - Modified Term
Descrizione

Other liver disease conditions - Modified Term

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C2826302
Other liver disease conditions - MedDRA Synonym
Descrizione

Other liver disease conditions - MedDRA Synonym

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C1140263
Other liver disease conditions - MedDRA lower level term code
Descrizione

Other liver disease conditions - MedDRA lower level term code

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C3898442
Other liver disease conditions - Failed coding
Descrizione

Other liver disease conditions - Failed coding

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Other liver disease conditions - Status
Descrizione

Other liver disease conditions - Status

Tipo di dati

text

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

Other medical conditions

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

Drug Allergies

Tipo di dati

integer

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

Rheumatoid Arthritis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Descrizione

Psoriasis

Tipo di dati

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Descrizione

Thyroid Disease

Tipo di dati

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Descrizione

Inflammatory Bowel Disease

Tipo di dati

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Descrizione

Lupus

Tipo di dati

integer

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

Sjogren's Syndrome

Tipo di dati

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Descrizione

Vitiligo

Tipo di dati

integer

Alias
UMLS CUI [1]
C0042900
Pharmacokinetics (Liver PK)
Descrizione

Pharmacokinetics (Liver PK)

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

Was a pharmacokinetic blood sample obtained?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
If pharmacokinetic blood sample was obtained, enter date and time sample taken
Descrizione

If pharmacokinetic blood sample was obtained, enter date and time sample taken

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0200345
If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
Descrizione

If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample

Tipo di dati

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0031328
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C1762893
UMLS CUI [3,1]
C0304229
UMLS CUI [3,2]
C0946444
Liver Biopsy
Descrizione

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Descrizione

Date of liver biopsy

Tipo di dati

date

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

Approximate size of liver biopsy

Tipo di dati

integer

Unità di misura
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Biopsy size unit
Descrizione

Biopsy size unit

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C1519795
UMLS CUI [1,3]
C0193388
Final Diagnosis
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C1546485
If other final diagnosis, please specify
Descrizione

If other final diagnosis, please specify

Tipo di dati

text

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

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
If other liver architecture, please specify
Descrizione

If other liver architecture, please specify

Tipo di dati

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
Descrizione

Check all that apply

Tipo di dati

text

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

If other description of liver cells or hepatocytes

Tipo di dati

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
Descrizione

Check all that apply

Tipo di dati

text

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

If other liver cell or hepatocyte inclusions or vacuoles, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1512693
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0042219
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Hepatocyte or Liver Cell Nuclear Abnormalities
Descrizione

Check all that apply

Tipo di dati

text

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

If other hepatocyte or liver cell nuclear abnormalities

Tipo di dati

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
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C1400896
If other liver or lobular infiltrates, please specify
Descrizione

If other liver or lobular infiltrates, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1400896
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Portal Tract Inflammation
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C3854488
If other portal tract inflammation, please specify
Descrizione

If other portal tract inflammation, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C3854488
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Bile Ducts
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C0005400
If other bile ducts, please specify
Descrizione

If other bile ducts, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0005400
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Portal Veins
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C0032718
If other portal veins, please specify
Descrizione

If other portal veins, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0032718
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver Infections
Descrizione

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1]
C1112211
If other liver infections, please specify
Descrizione

If other liver infections, please specify

Tipo di dati

text

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

Check all that apply

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [2]
C0555117
If other parasites or ova, please specify
Descrizione

If other parasites or ova, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0030498
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0555117
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Histologic Staining or Additional Studies Obtained
Descrizione

Histologic Staining or Additional Studies Obtained

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1524062
If other histologic staining or additional studies obtained, please specify
Descrizione

If other histologic staining or additional studies obtained, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C1524062
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
Liver imaging
Descrizione

Liver imaging

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

Date of hepatic or liver imaging test

Tipo di dati

date

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

What method was used for this imaging test?

Tipo di dati

text

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

If other method was used for this imaging test, specify

Tipo di dati

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?
Descrizione

Are images technically adequate?

Tipo di dati

text

Alias
UMLS CUI [1]
C0806487
If other image quality, please specify
Descrizione

If other image quality, please specify

Tipo di dati

text

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

Indicate the liver size

Tipo di dati

text

Alias
UMLS CUI [1]
C0426688
If other liver size, please specify
Descrizione

If other liver size, please specify

Tipo di dati

text

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

Indicate the liver texture

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0679033
UMLS CUI [1,2]
C0023884
If other liver texture, please specify
Descrizione

If other liver texture, please specify

Tipo di dati

text

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

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

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
If other diffuse and/or geographic fatty infiltrate of the liver, please specify
Descrizione

If other diffuse and/or geographic fatty infiltrate of the liver, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
UMLS CUI [2,1]
C0015695
UMLS CUI [2,2]
C1517526
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2348235
Ascites present
Descrizione

Ascites present

Tipo di dati

text

Alias
UMLS CUI [1]
C0003962
If other Ascites, please specify
Descrizione

If other Ascites, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Are Focal Hepatic Lesions characterisable?
Descrizione

Are Focal Hepatic Lesions characterisable?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If Focal Hepatic Lesions are characterisable, check all that apply
Descrizione

If Focal Hepatic Lesions are characterisable, check all that apply

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0577053
UMLS CUI [1,2]
C0205234
If other Focal Hepatic Lesions, please specify
Descrizione

If other Focal Hepatic Lesions, please specify

Tipo di dati

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?
Descrizione

Gallstones or gallbladder lesions?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3842395
UMLS CUI [1,2]
C0221198
If gallstones or gallbladder lesions are present, check all that apply
Descrizione

If gallstones or gallbladder lesions are present, check all that apply

Tipo di dati

text

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

If other gallstones or gallbladder lesions, please specify

Tipo di dati

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?
Descrizione

Biliary ductal lesions?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005423
UMLS CUI [1,2]
C0221198
If biliary ductal lesions are present, check all that apply
Descrizione

If biliary ductal lesions are present, check all that apply

Tipo di dati

text

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

If other biliary ductal lesions, please specify

Tipo di dati

text

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

Portal/Hepatic vein abnormalities?

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0032718
If portal/ hepatic vein abnormalities are present, check all that apply
Descrizione

If portal/ hepatic vein abnormalities are present, check all that apply

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0032718
If other portal/ hepatic vein abnormalities, please specify
Descrizione

If other portal/ hepatic vein abnormalities, please specify

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0019155
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0032718
UMLS CUI [1,4]
C0205394
UMLS CUI [1,5]
C2348235
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Similar models

Liver Events; Investigational Product (Liver); Alcohol Intake (Liver Alcohol); Medical Conditions; Pharmacokinetics (Liver); Liver Biopsy; Liver Imaging

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Liver Events
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Item
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
text
C0232741 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping criteria?
CL Item
ALT (alanine aminotransferase) (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 (OT)
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)
Were any diagnostic imaging tests of the liver or hepatobiliary system performed?
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])
C1456803 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C0040405 (UMLS CUI [4])
C0436427 (UMLS CUI [5])
C0024485 (UMLS CUI [6])
C0008310 (UMLS CUI [7])
If diagnostic imaging tests of liver were performed, were the results normal?
Item
If diagnostic imaging tests of liver or hepatobiliary system were performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C1711359 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0011923 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C1274040 (UMLS CUI [2,3])
Were any liver biopsies performed?
Item
Were any liver biopsies performed?
boolean
C0193388 (UMLS CUI [1])
Does the subject use 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
C1360419 (UMLS CUI [1])
C0002346 (UMLS CUI [2])
C0242295 (UMLS CUI [3])
C0042890 (UMLS CUI [4])
C0086190 (UMLS CUI [5])
Did the subject fast or undergo significant dietary change in the past week?
Item
Did the subject fast or undergo significant dietary change in the past week?
boolean
C3671772 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Item Group
Investigational Product (Liver)
C0304229 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
Item
If the liver event occurred during treatment period record start date of investigational product for that treatment period.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
Item
If the liver event occurred during treatment period record start date of investigational product for that treatment period - not applicable
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
C1272460 (UMLS CUI [4])
If the liver event occurred during treatment period record start date of investigational product for that treatment period - not applicable
Code List
If the liver event occurred during treatment period record start date of investigational product for that treatment period - not applicable
CL Item
Not applicable (1)
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
Item
If the liver event occurred during treatment period record stop date of investigational product for that treatment period.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0806020 (UMLS CUI [3,2])
Item
If the liver event occurred during treatment period record stop date of investigational product for that treatment period - not applicable
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0806020 (UMLS CUI [3,2])
C1272460 (UMLS CUI [4])
If the liver event occurred during treatment period record stop date of investigational product for that treatment period - not applicable
Code List
If the liver event occurred during treatment period record stop date of investigational product for that treatment period - not applicable
CL Item
Not applicable (1)
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
Item
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
Item
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event - not applicable
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
C1272460 (UMLS CUI [4])
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event - not applicable
Code List
If the liver event occurred after treatment period record start date of investigational product for the most recent period prior to the liver event - not applicable
CL Item
Not applicable (1)
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
Item
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event.
date
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0806020 (UMLS CUI [3,2])
Item
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event - not applicable
integer
C0023884 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0806020 (UMLS CUI [3,2])
C1272460 (UMLS CUI [4])
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event - not applicable
Code List
If the liver event occurred after treatment period record stop date of investigational product for the most recent period prior to the liver event - not applicable
CL Item
Not applicable (1)
Item Group
Alcohol intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948C0001948 (UMLS CUI [1])
Average number of units of alcohol consumed per week
Item
Average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Medical Conditions (Liver)
C0012634 (UMLS CUI-1)
C0023884 (UMLS CUI-2)
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 (5)
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 (5)
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 (5)
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 (5)
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 (5)
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 (5)
Item
Alcoholic Liver Disease
integer
C0023896 (UMLS CUI [1])
undefined item
Code List
Alcoholic Liver Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Non-alcoholic Steatohepatitis
integer
C3241937 (UMLS CUI [1])
Non-alcoholic Steatohepatitis
Code List
Non-alcoholic Steatohepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Fatty Liver
integer
C0015695 (UMLS CUI [1])
Fatty Liver
Code List
Fatty Liver
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hepatic Cirrhosis
integer
C0023890 (UMLS CUI [1])
Hepatic Cirrhosis
Code List
Hepatic Cirrhosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Hemochromatosis
integer
C0018995 (UMLS CUI [1])
Hemochromatosis
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Autoimmune Hepatitis
integer
C0241910 (UMLS CUI [1])
Autoimmune Hepatitis
Code List
Autoimmune Hepatitis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Gallbladder disease or biliary disease
integer
C0016977 (UMLS CUI [1,1])
C3275124 (UMLS CUI [1,2])
Gallbladder disease or biliary disease
Code List
Gallbladder disease or biliary disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Drug related liver disease conditions
C0023895 (UMLS CUI-1)
C0277579 (UMLS CUI-2)
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 (5)
Item Group
Other liver disease conditions
C0023895 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other liver disease conditions - Sequence Number
Item
Other liver disease conditions - Sequence Number
integer
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348184 (UMLS CUI [2])
Other liver disease conditions - Specific Condition
Item
Other liver disease conditions - Specific Condition
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other liver disease conditions - Modified Term
Item
Other liver disease conditions - Modified Term
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Other liver disease conditions - MedDRA Synonym
Item
Other liver disease conditions - MedDRA Synonym
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
Other liver disease conditions - MedDRA lower level term code
Item
Other liver disease conditions - MedDRA lower level term code
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3898442 (UMLS CUI [2])
Other liver disease conditions - Failed coding
Item
Other liver disease conditions - Failed coding
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
Other liver disease conditions - Status
text
C0023895 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
Status
Code List
Other liver disease conditions - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Other medical conditions
C0012634 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Item
Drug Allergies
integer
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 (5)
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 (5)
Item
Psoriasis
integer
C0033860 (UMLS CUI [1])
Psoriasis
Code List
Psoriasis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Thyroid Disease
integer
C0040128 (UMLS CUI [1])
Thyroid Disease
Code List
Thyroid Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Inflammatory Bowel Disease
integer
C0021390 (UMLS CUI [1])
Inflammatory Bowel Disease
Code List
Inflammatory Bowel Disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Lupus
integer
C0409974 (UMLS CUI [1])
Lupus
Code List
Lupus
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Sjogren's Syndrome
integer
C1527336 (UMLS CUI [1])
Sjogren's Syndrome
Code List
Sjogren's Syndrome
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item
Vitiligo
integer
C0042900 (UMLS CUI [1])
Vitiligo
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (5)
Item Group
Pharmacokinetics (Liver PK)
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])
If pharmacokinetic blood sample was obtained, enter date and time sample taken
Item
If pharmacokinetic blood sample was obtained, enter date and time sample taken
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
Item
If pharmacokinetic blood sample was obtained, enter date and time of last investigational product dose prior to PK sample
datetime
C0005834 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1762893 (UMLS CUI [2,2])
C0304229 (UMLS CUI [3,1])
C0946444 (UMLS CUI [3,2])
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
integer
C1299482 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
Biopsy size unit
Item
Biopsy size unit
text
C1299482 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C0193388 (UMLS CUI [1,3])
Item
Final Diagnosis
text
C1546485 (UMLS CUI [1])
Final Diagnosis
Code List
Final Diagnosis
CL Item
Normal (0)
CL Item
Acute hepatitis (1)
CL Item
Chronic hepatitis (2)
CL Item
Cholestatic hepatitis (3)
CL Item
Drug-induced cholestasis (4)
CL Item
Acute viral hepatitis (5)
CL Item
Chronic viral hepatitis (6)
CL Item
Drug-induced hepatitis (7)
CL Item
Autoimmune hepatitis (8)
CL Item
Bridging necrosis (9)
CL Item
Submassive hepatic necrosis (10)
CL Item
Massive hepatic necrosis (11)
CL Item
Steatosis - microvesicular (12)
CL Item
Steatosis - macrovesicular (13)
CL Item
Steatosis - mixed (14)
CL Item
Non-alcoholic steatohepatitis (15)
CL Item
Alcoholic hepatitis (16)
CL Item
Hepatic granulomas (17)
CL Item
Sarcoidosis (18)
CL Item
Fibrosis (19)
CL Item
Cirrhosis (20)
CL Item
Primary biliary cirrhosis (21)
CL Item
Primary sclerosing cholangitis (22)
CL Item
Autoimmune overlap syndrome (23)
CL Item
Hemochromatosis (24)
CL Item
Alpha-1-antitrypsin deficiency (25)
CL Item
Wilson's disease (26)
CL Item
Veno-occlusive disease (27)
CL Item
Budd-Chiari syndrome (28)
CL Item
Neoplasia (29)
CL Item
Other, specify (99)
If other final diagnosis, please specify
Item
If other final diagnosis, please specify
text
C1546485 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver Architecture
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
Liver Architecture
Code List
Liver Architecture
CL Item
Normal (B1)
CL Item
Bridging fibrosis (B2)
CL Item
Diffuse fibrosis (B3)
CL Item
Nodular regenerative hyperplasia (B4)
CL Item
Congenital hepatic fibrosis (B5)
CL Item
Cirrhosis (B6)
CL Item
Centrilobular congestion (B7)
CL Item
Endophlebitis (B8)
CL Item
Veno-occlusive disease (B9)
CL Item
Canalicular cholestasis (B10)
CL Item
Apoptosis (B11)
CL Item
Focal (or spotty or mild) hepatocellular necrosis (B12)
CL Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis) (B13)
CL Item
Ischaemic necrosis (B14)
CL Item
Centrolobular (Zone 3) necrosis (B15)
CL Item
Focal coagulative necrosis (B16)
CL Item
Centrolobular (Zone 3) coagulative necrosis (B17)
CL Item
Bridging hepatocellular necrosis (B18)
CL Item
Massive or panlobular hepatocellular necrosis (B19)
CL Item
Dysplasia (B20)
CL Item
Neoplasia (B21)
CL Item
Other, specify (B99)
If other liver architecture, please specify
Item
If other liver architecture, please 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
text
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 (C0)
CL Item
Ballooning (C1)
CL Item
Acidophilic (C2)
CL Item
Pseudoxanthomatous (C3)
CL Item
Multinucleated giant hepatocytes (C4)
CL Item
Other, specify (C99)
If other description of liver cells or hepatocytes
Item
If other description of liver cells or hepatocytes
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
text
C0227525 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0042219 (UMLS CUI [2])
Liver Cell or Hepatocyte Inclusions or Vacuoles
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
No inclusions (D0)
CL Item
Macrovesicular steatosis (D1)
CL Item
Microvesicular steatosis (D2)
CL Item
Bile accumulation (D3)
CL Item
Diastase-resistant, PAS-positive cytoplasmic inclusions (D4)
CL Item
Alpha-1-antitrypsin inclusions (D5)
CL Item
Megamitochondria (D6)
CL Item
Mallory bodies (D7)
CL Item
"Ground Glass" inclusions (D8)
CL Item
Lipofuscin pigment (D9)
CL Item
Hemosiderin granules (D10)
CL Item
Orcein-positive cytoplasmin granules (D11)
CL Item
Protoporphyrin crystals (birefringent under polarised light) (D12)
CL Item
Uroporphyrin crystals (red fluorescence under ultraviolet light) (D13)
CL Item
Other, specify (D99)
If other liver cell or hepatocyte inclusions or vacuoles, please specify
Item
If other liver cell or hepatocyte inclusions or vacuoles, please specify
text
C0227525 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0042219 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
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 (E0)
CL Item
Hepatocellular mitosis (E1)
CL Item
Binucleated or multinucleated hepatocytes (E2)
CL Item
CMV inclusion bodies (E3)
CL Item
HSV inclusions (E4)
CL Item
Varicella inclusions (E5)
CL Item
Other, specify (E99)
If other hepatocyte or liver cell nuclear abnormalities
Item
If other hepatocyte or liver cell nuclear abnormalities
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
text
C1400896 (UMLS CUI [1])
Liver or Lobular Infiltrates
Code List
Liver or Lobular Infiltrates
CL Item
None (F0)
CL Item
Eosinophils (F1)
CL Item
Lymphocytes (F2)
CL Item
Plasma cells (F3)
CL Item
Neutrophils (F4)
CL Item
Macrophages and proliferating Kupffer cells (F5)
CL Item
Granulomas (F6)
CL Item
Other, specify (F99)
If other liver or lobular infiltrates, please specify
Item
If other liver or lobular infiltrates, please specify
text
C1400896 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
Portal Tract Inflammation
Code List
Portal Tract Inflammation
CL Item
None (G0)
CL Item
Eosinophils (G1)
CL Item
Lymphoid aggregates and/or follicles (G2)
CL Item
Plasma cells (G3)
CL Item
Neutrophils (G4)
CL Item
Histocytes and macrophages (G5)
CL Item
Other, specify (G99)
If other portal tract inflammation, please specify
Item
If other portal tract inflammation, please specify
text
C3854488 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Bile Ducts
text
C0005400 (UMLS CUI [1])
Bile Ducts
Code List
Bile Ducts
CL Item
Normal (H0)
CL Item
Proliferation of bile ducts (bile ductular reaction) (H1)
CL Item
Dilation, degeneration or disruption of portal bile ducts (H2)
CL Item
Paucity of bile ducts (H3)
CL Item
Periductal fibrosis (H4)
CL Item
Other, specify (H99)
If other bile ducts, please specify
Item
If other bile ducts, please specify
text
C0005400 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Portal Veins
text
C0032718 (UMLS CUI [1])
Portal Veins
Code List
Portal Veins
CL Item
Normal (I0)
CL Item
Pyelophlebitis (I1)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (I2)
CL Item
Neoplastic invasion of portal vein (I3)
CL Item
Granulomatous compression of portal vein (I4)
CL Item
Other, specify (I99)
If other portal veins, please specify
Item
If other portal veins, please specify
text
C0032718 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Liver Infections
text
C1112211 (UMLS CUI [1])
Liver Infections
Code List
Liver Infections
CL Item
Normal (J0)
CL Item
Leishmaniasis donovani (J1)
CL Item
Plasmodium falciparum (J2)
CL Item
Toxoplasmosis (J3)
CL Item
Cryptococcus neoformans (J4)
CL Item
Histoplasma capsulatum (J5)
CL Item
Mycobacterium tuberculois (J6)
CL Item
Other mycobacterial species (J7)
CL Item
Other, specify (J99)
If other liver infections, please specify
Item
If other liver infections, please specify
text
C1112211 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Parasites or Ova
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [2])
Parasites or Ova
Code List
Parasites or Ova
CL Item
None (K0)
CL Item
Schistosome and/or ova (K1)
CL Item
Ascaris and/or ova (K2)
CL Item
Toxocara and/or ova (K3)
CL Item
Echinococcus cysts (K4)
CL Item
Hepatic capillariasis worms and/or ova (K5)
CL Item
Other, specify (K99)
If other parasites or ova, please specify
Item
If other parasites or ova, please specify
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0555117 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Item
Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
Histologic Staining or Additional Studies Obtained
Code List
Histologic Staining or Additional Studies Obtained
CL Item
Haematoxylin and eosin (or H & E) (L1)
CL Item
Masson (L2)
CL Item
Toluidine blue or Giemsa (L3)
CL Item
Prussian blue (L4)
CL Item
Periodic Acidic Schiff (PAS), with or without diastase (L5)
CL Item
Oil red O (L6)
CL Item
Congo red (L7)
CL Item
Hall's stain (L8)
CL Item
Gridley's stain (L9)
CL Item
Rhodanine (copper) (L10)
CL Item
Rubeanic acid (copper)  (L11)
CL Item
Orcein, aldehyde fuchsin or Victoria blue (L12)
CL Item
Electron microscopy (L13)
CL Item
Hepatitis A immunostains positive (L14)
CL Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive (L15)
CL Item
Hepatitis D immunostains (L16)
CL Item
Other immunostains (L17)
CL Item
Other, specify (L99)
If other histologic staining or additional studies obtained, please specify
Item
If other histologic staining or additional studies obtained, please specify
text
C0487602 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Item Group
Liver imaging
C2711860 (UMLS CUI-1)
Date of hepatic or liver imaging test
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?
text
C2711860 (UMLS CUI [1,1])
C1275506 (UMLS CUI [1,2])
What method was 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: A200 (OT)
If other method was used for this imaging test, specify
Item
If other method was used for this 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?
text
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: (OT)
If other image quality, please specify
Item
If other image quality, please specify
text
C0806487 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver size
text
C0426688 (UMLS CUI [1])
Indicate the liver size
Code List
Indicate the liver size
CL Item
Normal size (A1)
CL Item
Hypertrophy (or enlarged) (A2)
CL Item
Atrophy (or smaller than normal) (A3)
CL Item
Segmental hypertrophy (A4)
CL Item
Other, specify: (A99)
If other liver size, please specify
Item
If other liver size, please specify
text
C0426688 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item
Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
Indicate the liver texture
Code List
Indicate the liver texture
CL Item
Normal (B1)
CL Item
Heterogenous (B2)
CL Item
Suggestive of fibrosis (B3)
CL Item
Nodular or suggestive of cirrhosis (B4)
CL Item
Other, specify (B99)
If other liver texture, please specify
Item
If other liver texture, please specify
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
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 (C1)
CL Item
Mild (<=25%) (C2)
CL Item
Moderate (>25% to <75%) (C3)
CL Item
Severe (>=75%) (C4)
CL Item
Other, specify (C99)
If other diffuse and/or geographic fatty infiltrate of the liver, please specify
Item
If other diffuse and/or geographic fatty infiltrate of the liver, please specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0015695 (UMLS CUI [2,1])
C1517526 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
Item
Ascites present
text
C0003962 (UMLS CUI [1])
Ascites present
Code List
Ascites present
CL Item
None present (D1)
CL Item
Yes - small amount (D2)
CL Item
Yes - moderate or severe amount (D3)
CL Item
Other, specify (D99)
If other Ascites, please specify
Item
If other Ascites, please specify
text
C0003962 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Are Focal Hepatic Lesions characterisable?
Item
Are Focal Hepatic Lesions characterisable?
boolean
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Item
If Focal Hepatic Lesions are characterisable, check all that apply
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
If Focal Hepatic Lesions are characterisable, check all that apply
Code List
If Focal Hepatic Lesions are characterisable, check all that apply
CL Item
Solid (E1)
CL Item
Cystic (E2)
CL Item
Hemangioma (E3)
CL Item
Focal Nodular Hyperplasia (E4)
CL Item
Other, specify (E99)
If other Focal Hepatic Lesions, please specify
Item
If other Focal Hepatic Lesions, please specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Gallstones or gallbladder lesions?
Item
Gallstones or gallbladder lesions?
boolean
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
If gallstones or gallbladder lesions are present, check all that apply
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
If gallstones or gallbladder lesions are present, check all that apply
Code List
If gallstones or gallbladder lesions are present, check all that apply
CL Item
Gallstones (F1)
CL Item
Gallbladder polyp(s) (F2)
CL Item
Sludge (F3)
CL Item
Gallbladder wall thickening/oedema (F4)
CL Item
Gallbladder wall gas (F5)
CL Item
Cholecystitis (F6)
CL Item
Gallbladder wall calcification (F7)
CL Item
Gallbladder mass (F8)
CL Item
Other, specify (F99)
If other gallstones or gallbladder lesions, please specify
Item
If other gallstones or gallbladder lesions, please specify
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Biliary ductal lesions?
Item
Biliary ductal lesions?
boolean
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Item
If biliary ductal lesions are present, check all that apply
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
If biliary ductal lesions are present, check all that apply
Code List
If biliary ductal lesions are present, check all that apply
CL Item
Intrahepatic ductal dilation (focal involving the right hepatic lobe) (G1)
CL Item
Intrahepatic ductal dilation (focal involving the left hepatic lobe) (G2)
CL Item
Intrahepatic ductal dilation (focal involving both right and left hepatic lobes) (G3)
CL Item
Extrahepatic ductal dilation (G4)
CL Item
Diffuse ductal dilation (involving both intrahepatic and extrahepatic ducts) (G5)
CL Item
Acute Cholangitis (G6)
CL Item
Primary sclerosing cholangitis (G7)
CL Item
Choledocholithiasis (gallstone in duct) (G8)
CL Item
Ductal filling defect(s), other than gallstone (G9)
CL Item
Ductal wall thickening or oedema (G10)
CL Item
Choledochal cyst (G11)
CL Item
Ductal mass (G12)
CL Item
Extrinsic mass compressing bile duct(s) (G13)
CL Item
Other, specify (G99)
If other biliary ductal lesions, please specify
Item
If other biliary ductal lesions, please specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Portal/Hepatic vein abnormalities?
Item
Portal/Hepatic vein abnormalities?
boolean
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
Item
If portal/ hepatic vein abnormalities are present, check all that apply
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
If portal/ hepatic vein abnormalities are present, check all that apply
Code List
If portal/ hepatic vein abnormalities are present, check all that apply
CL Item
Portal vein enlargement (H1)
CL Item
Hepatic vein enlargement (H2)
CL Item
Nonocclusive portal vein thrombosis (H3)
CL Item
Occlusive portal vein thrombosis - bland (H4)
CL Item
Hepatic vein thrombosis - bland (H5)
CL Item
Occlusive portal vein thrombosis - malignant (H6)
CL Item
Hepatic vein thrombosis - malignant (H7)
CL Item
Involvement of the main portal vein (H8)
CL Item
Involvement of the right portal vein (H9)
CL Item
Involvement of the left portal vein (H10)
CL Item
Budd-Chiari syndrome (H11)
CL Item
Other, specify (H99)
If other portal/ hepatic vein abnormalities, please specify
Item
If other portal/ hepatic vein abnormalities, please specify
text
C0019155 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0032718 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
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