ID

40082

Description

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Keywords

  1. 3/11/20 3/11/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 11, 2020

DOI

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License

Creative Commons BY-NC 4.0

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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Liver Event Details

  1. StudyEvent: ODM
    1. Liver Event Details
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Date of visit/ assessment
Description

Date of visit/ assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Liver event assessment
Description

Liver event assessment

Alias
UMLS CUI-1
C0023884
UMLS CUI-2
C0877248
UMLS CUI-3
C0220825
Is this liver event a serious adverse event?
Description

If yes, please complete liver event forms and serious adverse event form immediately.

Data type

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?
Description

Check all that apply

Data type

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?
Description

Is the subject age 55 or older?

Data type

boolean

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

If yes, ensure Pregnancy Notification Form has been completed.

Data type

text

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

Diagnostic Imaging; Liver | Diagnostic Imaging; Hepatobiliary System | Ultrasonics (sound); Liver | CT without contrast | Magnetic Resonance Imaging | Endoscopic Retrograde Cholangiopancreatography

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C0023884
UMLS CUI [2,1]
C0011923
UMLS CUI [2,2]
C1711359
UMLS CUI [3,1]
C1456803
UMLS CUI [3,2]
C0023884
UMLS CUI [4]
C1275400
UMLS CUI [5]
C0024485
UMLS CUI [6]
C0008310
If diagostic imaging was performed, were the results normal?
Description

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

Data type

boolean

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

If yes complete Liver Biopsy form.

Data type

boolean

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

If yes record on the appropriate Concomitant Medication form.

Data type

boolean

Alias
UMLS CUI [1,1]
C2240391
UMLS CUI [1,2]
C1148474
UMLS CUI [1,3]
C0002346
UMLS CUI [1,4]
C0242295
UMLS CUI [1,5]
C0281875
Did the subject fast or undergo significant dietary change in the past week?
Description

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

Data type

boolean

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

Investigational Product (Liver)

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

When did the liver event occur?

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C2745955
Start Date Investigational Product (During treatment period)
Description

Start Date Investigational Product (During treatment period)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
End Date Investigational Product (During treatment period)
Description

End Date Investigational Product (During treatment period)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0347984
Start Date Investigational Product (After treatment period)
Description

Start Date Investigational Product (After treatment period)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0808070
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
End Date Investigational Product (After treatment period)
Description

End Date Investigational Product (After treatment period)

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0806020
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C0687676
Pharmacokinetics (Liver)
Description

Pharmacokinetics (Liver)

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

Was a pharmacokinetic blood sample obtained?

Data type

boolean

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

Date and time sample take

Data type

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
Date and time of last double masked product prior to PK sample
Description

Double masked product = Eye Drops

Data type

datetime

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0013072
UMLS CUI [1,3]
C1762893
UMLS CUI [2,1]
C0304229
UMLS CUI [2,2]
C0013072
UMLS CUI [2,3]
C0946444
UMLS CUI [3,1]
C0201734
UMLS CUI [3,2]
C0178913
UMLS CUI [3,3]
C0332152
Date and time of last ranibizumab dose prior to PK sample
Description

Date and time of last ranibizumab dose prior to PK sample

Data type

datetime

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C1566537
UMLS CUI [2,1]
C0946444
UMLS CUI [2,2]
C1566537
UMLS CUI [3,1]
C0201734
UMLS CUI [3,2]
C0178913
UMLS CUI [3,3]
C0332152
Alcohol intake at onset of liver event
Description

Alcohol intake at onset of liver event

Alias
UMLS CUI-1
C0001948
UMLS CUI-2
C2985916
UMLS CUI-3
C0023884
Does the subject consume alcohol?
Description

Does the subject consume alcohol?

Data type

boolean

Alias
UMLS CUI [1]
C0001948
If yes, record the average number of units of alcohol consumed per week
Description

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

Data type

float

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

Substance Use Type

Data type

text

Alias
UMLS CUI [1,1]
C0439861
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0332307
Medical conditions at onset of liver event - Liver disease medical conditions
Description

Medical conditions at onset of liver event - Liver disease medical conditions

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

Acute Viral Hepatitis A

Data type

integer

Alias
UMLS CUI [1]
C0276434
Chronic Hepatitis B
Description

Chronic Hepatitis B

Data type

integer

Alias
UMLS CUI [1]
C0524909
Chronic Hepatitis C
Description

Chronic Hepatitis C

Data type

integer

Alias
UMLS CUI [1]
C0524910
Cytomegalovirus Hepatitis
Description

Cytomegalovirus Hepatitis

Data type

integer

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

Epstein Barr Virus Infectious Mononucleosis

Data type

integer

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

Herpes Simplex Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C1963747
Alcoholic Liver Disease
Description

Alcoholic Liver Disease

Data type

integer

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

Non-alcoholic Steatohepatitis

Data type

integer

Alias
UMLS CUI [1]
C3241937
Fatty Liver
Description

Fatty Liver

Data type

integer

Alias
UMLS CUI [1]
C0015695
Hepatic Cirrhosis
Description

Hepatic Cirrhosis

Data type

integer

Alias
UMLS CUI [1]
C0023890
Hemochromatosis
Description

Hemochromatosis

Data type

integer

Alias
UMLS CUI [1]
C0018995
Autoimmune Hepatitis
Description

Autoimmune Hepatitis

Data type

integer

Alias
UMLS CUI [1]
C1320722
Gallbladder disease
Description

Gallbladder disease

Data type

integer

Alias
UMLS CUI [1]
C0016977
Medical conditions at onset of liver event - Drug related disease conditions
Description

Medical conditions at onset of liver event - Drug related disease conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
UMLS CUI-5
C0277579
Drug related liver disease
Description

Drug related liver disease

Data type

integer

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0277579
Medical conditions at onset of liver event - Other liver disease conditions
Description

Medical conditions at onset of liver event - Other liver disease conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
UMLS CUI-5
C0205394
Other liver disease conditions - Sequence Number
Description

Other liver disease conditions - Sequence Number

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0023884
UMLS CUI [1,3]
C0205394
UMLS CUI [2]
C2348184
Specific Condition
Description

Specific Condition

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
Specific condition - Modified Term
Description

Specific condition - Modified Term

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C2826302
Specific condition - MedDRA Synonym
Description

Specific condition - MedDRA Synonym

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C1140263
Specific condition - MedDRA lower level term code
Description

Specific condition - MedDRA lower level term code

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C3898442
Specific condition - Failed coding
Description

Specific condition - Failed coding

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0805701
UMLS CUI [2,2]
C0231175
Specific condition - Status
Description

Specific condition - Status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348235
UMLS CUI [2]
C0449438
Medical conditions at onset of liver event - Other liver disease conditions
Description

Medical conditions at onset of liver event - Other liver disease conditions

Alias
UMLS CUI-1
C0012634
UMLS CUI-2
C0332162
UMLS CUI-3
C0877248
UMLS CUI-4
C0023884
UMLS CUI-5
C0205394
Drug Allergies
Description

Drug Allergies

Data type

integer

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

Rheumatoid Arthritis

Data type

integer

Alias
UMLS CUI [1]
C0003873
Psoriasis
Description

Psoriasis

Data type

integer

Alias
UMLS CUI [1]
C0033860
Thyroid Disease
Description

Thyroid Disease

Data type

integer

Alias
UMLS CUI [1]
C0040128
Inflammatory Bowel Disease
Description

Inflammatory Bowel Disease

Data type

integer

Alias
UMLS CUI [1]
C0021390
Lupus
Description

Lupus

Data type

integer

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

Sjogren's Syndrome

Data type

integer

Alias
UMLS CUI [1]
C1527336
Vitiligo
Description

Vitiligo

Data type

integer

Alias
UMLS CUI [1]
C0042900
Liver Biopsy
Description

Liver Biopsy

Alias
UMLS CUI-1
C0193388
Date of liver biopsy
Description

Date of liver biopsy

Data type

date

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

Approximate size of liver biopsy

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1299482
UMLS CUI [1,2]
C0193388
mm
Final Diagnosis
Description

Check all that apply

Data type

text

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

If other final diagnosis, specify

Data type

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Liver architecture
Description

Check all that apply

Data type

text

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

If other liver architecture, specify

Data type

text

Alias
UMLS CUI [1,1]
C0023884
UMLS CUI [1,2]
C0935919
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Description of Liver Cells or Hepatocytes
Description

Check all that apply

Data type

text

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

If other description of liver cells or hepatocytes, specify

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C0678257
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Check all that apply

Data type

text

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
Description

If other liver cell or hepatocyte inclusions or vacuoles, specify

Data type

text

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

Check all that apply

Data type

text

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

If other hepatocyte or liver cell nuclear abnormalities, specify

Data type

text

Alias
UMLS CUI [1,1]
C0227525
UMLS CUI [1,2]
C1849376
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver or Lobular Infiltrates
Description

Check all that apply

Data type

text

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

If other liver or lobular infiltrates, specify

Data type

text

Alias
UMLS CUI [1,1]
C0205417
UMLS CUI [1,2]
C1400896
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Portal Tract Inflammation
Description

Check all that apply

Data type

text

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

If other portal tract inflammation, specify

Data type

text

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

Check all that apply

Data type

text

Alias
UMLS CUI [1]
C0005400
If other bile duct structure, specify
Description

If other bile duct structure, specify

Data type

text

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

Check all that apply

Data type

text

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

If other portal vein structure, specify

Data type

text

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

Check all that apply

Data type

text

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

If other liver infections, specify

Data type

text

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

Check all that apply

Data type

text

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

If other parasites or ova, specify

Data type

text

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

Histologic Staining or Additional Studies Obtained

Data type

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0193388
If other histologic staining or additional studies obtained, specify
Description

If other histologic staining or additional studies obtained, specify

Data type

text

Alias
UMLS CUI [1,1]
C0487602
UMLS CUI [1,2]
C0430022
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0193388
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C2348235
Liver Imaging
Description

Liver Imaging

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

Date of hepatic or liver imaging test

Data type

date

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

What method was used for this imaging test?

Data type

text

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

If other method was used for this imaging test, specify

Data type

text

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

Are images technically adequate?

Data type

text

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

If other image quality, specify

Data type

text

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

Indicate the liver size

Data type

text

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

If other liver size, specify

Data type

text

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

Indicate the liver texture

Data type

text

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

If other liver texture, specify

Data type

text

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

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

Data type

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [2]
C0441800
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0015695
UMLS CUI [1,2]
C0205219
UMLS CUI [1,3]
C1517526
UMLS CUI [2]
C0441800
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235
Ascites present
Description

Ascites present

Data type

text

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

If other ascites, specify

Data type

text

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

Check all that apply

Data type

text

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

If other focal hepatic lesions, specify

Data type

text

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

Check all that apply

Data type

text

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

If other gallstones or gallbladder lesions, specify

Data type

text

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

Check all that apply

Data type

text

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

If other biliary ductal lesions, specify

Data type

text

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

Check all that apply

Data type

text

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

If other portal/hepatic vein abnormalities, specify?

Data type

text

Alias
UMLS CUI [1]
C0019155
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C0032718
UMLS CUI [3,1]
C0205394
UMLS CUI [3,2]
C2348235

Similar models

Liver Event Details

  1. StudyEvent: ODM
    1. Liver Event Details
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Date of visit/ assessment
Item
Date of visit/ assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Liver event assessment
C0023884 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
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?
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])
Code List
Which liver chemistry result reached or exceeded protocol-defined investigational product stopping/interruption 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])
Code List
If female, is the subject pregnant?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not applicable (X)
Diagnostic Imaging; Liver | Diagnostic Imaging; Hepatobiliary System | Ultrasonics (sound); Liver | CT without contrast | Magnetic Resonance Imaging | Endoscopic Retrograde Cholangiopancreatography
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])
C0023884 (UMLS CUI [1,2])
C0011923 (UMLS CUI [2,1])
C1711359 (UMLS CUI [2,2])
C1456803 (UMLS CUI [3,1])
C0023884 (UMLS CUI [3,2])
C1275400 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C0008310 (UMLS CUI [6])
If diagostic imaging was performed, were the results normal?
Item
If diagostic imaging was performed, were the results normal?
boolean
C0011923 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2])
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
C2240391 (UMLS CUI [1,1])
C1148474 (UMLS CUI [1,2])
C0002346 (UMLS CUI [1,3])
C0242295 (UMLS CUI [1,4])
C0281875 (UMLS CUI [1,5])
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
C0015663 (UMLS CUI [1])
C3671772 (UMLS CUI [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])
Code List
When did the liver event occur?
CL Item
During the treatment period: If the liver event occurred 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 occurred after treatment period record start and stop date of investigational product for the most recent period prior to the liver event. (A)
Start Date Investigational Product (During treatment period)
Item
Start Date Investigational Product (During treatment period)
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
End Date Investigational Product (During treatment period)
Item
End Date Investigational Product (During treatment period)
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
Start Date Investigational Product (After treatment period)
Item
Start Date Investigational Product (After treatment period)
date
C0304229 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
End Date Investigational Product (After treatment period)
Item
End Date Investigational Product (After treatment period)
date
C0304229 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
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 take
Item
Date and time sample take
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Date and time of last double masked product prior to PK sample
Item
Date and time of last double masked product prior to PK sample
datetime
C0304229 (UMLS CUI [1,1])
C0013072 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C0013072 (UMLS CUI [2,2])
C0946444 (UMLS CUI [2,3])
C0201734 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Date and time of last ranibizumab dose prior to PK sample
Item
Date and time of last ranibizumab dose prior to PK sample
datetime
C1762893 (UMLS CUI [1,1])
C1566537 (UMLS CUI [1,2])
C0946444 (UMLS CUI [2,1])
C1566537 (UMLS CUI [2,2])
C0201734 (UMLS CUI [3,1])
C0178913 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
Item Group
Alcohol intake at onset of liver event
C0001948 (UMLS CUI-1)
C2985916 (UMLS CUI-2)
C0023884 (UMLS CUI-3)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
If yes, record the average number of units of alcohol consumed per week
Item
If yes, record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Substance Use Type
Item
Substance Use Type
text
C0439861 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Item Group
Medical conditions at onset of liver event - Liver disease medical conditions
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
Code List
Hemochromatosis
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item
Autoimmune Hepatitis
integer
C1320722 (UMLS CUI [1])
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])
Code List
Gallbladder disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Medical conditions at onset of liver event - Drug related disease conditions
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0277579 (UMLS CUI-5)
Item
Drug related liver disease
integer
C0023895 (UMLS CUI [1,1])
C0277579 (UMLS CUI [1,2])
Code List
Drug related liver disease
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
Item Group
Medical conditions at onset of liver event - Other liver disease conditions
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Other liver disease conditions - Sequence Number
Item
Other liver disease conditions - Sequence Number
integer
C0012634 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348184 (UMLS CUI [2])
Specific Condition
Item
Specific Condition
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Specific condition - Modified Term
Item
Specific condition - Modified Term
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2826302 (UMLS CUI [2])
Specific condition - MedDRA Synonym
Item
Specific condition - MedDRA Synonym
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
Specific condition - MedDRA lower level term code
Item
Specific condition - MedDRA lower level term code
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C3898442 (UMLS CUI [2])
Specific condition - Failed coding
Item
Specific condition - Failed coding
text
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Item
Specific condition - Status
integer
C0012634 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0449438 (UMLS CUI [2])
Code List
Specific condition - Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Medical conditions at onset of liver event - Other liver disease conditions
C0012634 (UMLS CUI-1)
C0332162 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0023884 (UMLS CUI-4)
C0205394 (UMLS CUI-5)
Item
Drug Allergies
integer
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
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])
Code List
Vitiligo
CL Item
Current (1)
CL Item
Past (2)
CL Item
No Medical Condition (3)
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])
Item
Final Diagnosis
text
C1546485 (UMLS CUI [1])
Code List
Final Diagnosis
CL Item
Normal (A0)
CL Item
Acute hepatitis (A1)
CL Item
Chronic hepatitis (A2)
CL Item
Cholestatic hepatitis (A3)
CL Item
Drug-induced cholestasis (A4)
CL Item
Acute viral hepatitis (A5)
CL Item
Chronic viral hepatitis (A6)
CL Item
Drug-induced hepatitis (A7)
CL Item
Autoimmune hepatitis (A8)
CL Item
Bridging necrosis (A9)
CL Item
Submassive hepatic necrosis (A10)
CL Item
Massive hepatic necrosis (A11)
CL Item
Steatosis - microvesicular (A12)
CL Item
Steatosis - macrovesicular (A13)
CL Item
Steatosis - mixed (A14)
CL Item
Non-alcoholic steatohepatitis (A15)
CL Item
Alcoholic hepatitis (A16)
CL Item
Hepatic granulomas (A17)
CL Item
Sarcoidosis (A18)
CL Item
Fibrosis (A19)
CL Item
Cirrhosis (A20)
CL Item
Primary biliary cirrhosis (A21)
CL Item
Primary sclerosing cholangitis (A22)
CL Item
Autoimmune overlap syndrome (A23)
CL Item
Hemochromatosis (A24)
CL Item
Alpha-1-antitrypsin deficiency (A25)
CL Item
Wilson's disease (A26)
CL Item
Veno-occlusive disease (A27)
CL Item
Budd-Chiari syndrome (A28)
CL Item
Neoplasia (A29)
CL Item
Other, specify (A99)
If other final diagnosis, specify
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
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
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, specify
Item
If other liver architecture, specify
text
C0023884 (UMLS CUI [1,1])
C0935919 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Description of Liver Cells or Hepatocytes
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Code List
Description of Liver Cells or Hepatocytes
CL Item
Normal (C0)
CL Item
Ballooning (C1)
CL Item
Acidophilic (C2)
CL Item
Pseudoxanthomathous (C3)
CL Item
Multinucleated giant hepatocytes (C4)
CL Item
Other, specify (C99)
If other description of liver cells or hepatocytes, specify
Item
If other description of liver cells or hepatocytes, specify
text
C0227525 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver Cell or Hepatocyte Inclusions or Vacuoles
text
C0227525 (UMLS CUI [1,1])
C0042219 (UMLS CUI [1,2])
C1512693 (UMLS CUI [1,3])
Code List
Liver Cell or Hepatocyte Inclusions or Vacuoles
CL Item
Normal (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
Orcein-positive cytoplasmin granules (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, specify
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Hepatocyte or Liver Cell Nuclear Abnormalities
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
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, specify
Item
If other hepatocyte or liver cell nuclear abnormalities, specify
text
C0227525 (UMLS CUI [1,1])
C1849376 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver or Lobular Infiltrates
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
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, specify
Item
If other liver or lobular infiltrates, specify
text
C0205417 (UMLS CUI [1,1])
C1400896 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal Tract Inflammation
text
C3854488 (UMLS CUI [1])
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, specify
Item
If other portal tract inflammation, specify
text
C3854488 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Bile Ducts
text
C0005400 (UMLS CUI [1])
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 duct structure, specify
Item
If other bile duct structure, specify
text
C0005400 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal Veins
text
C0032718 (UMLS CUI [1])
Code List
Portal Veins
CL Item
Nomal (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 vein structure, specify
Item
If other portal vein structure, specify
text
C0032718 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Liver Infections
text
C1112211 (UMLS CUI [1])
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, specify
Item
If other liver infections, specify
text
C1112211 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Parasites or Ova
text
C0030498 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0555117 (UMLS CUI [1,3])
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, specify
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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Histologic Staining or Additional Studies Obtained
text
C0487602 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
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, specify
Item
If other histologic staining or additional studies obtained, specify
text
C0487602 (UMLS CUI [1,1])
C0430022 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
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])
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 (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 [2,1])
C2348235 (UMLS CUI [2,2])
Item
Are images technically adequate?
text
C0806487 (UMLS CUI [1])
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, specify
Item
If other image quality, specify
text
C0806487 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Indicate the liver size
text
C0426688 (UMLS CUI [1])
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 (OT)
If other liver size, specify
Item
If other liver size, specify
text
C0426688 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Indicate the liver texture
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
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 (OT)
If other liver texture, specify
Item
If other liver texture, specify
text
C0679033 (UMLS CUI [1,1])
C0023884 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Grade the diffuse and/or geographic fatty infiltrate of the liver
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2])
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 (OT)
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
Item
If other grade of diffuse and/or geographic fatty infiltrate of the liver, specify
text
C0015695 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C1517526 (UMLS CUI [1,3])
C0441800 (UMLS CUI [2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Item
Ascites present
text
C0003962 (UMLS CUI [1])
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 (OT)
If other ascites, specify
Item
If other ascites, specify
text
C0003962 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Are Focal Hepatic Lesions characterisable?
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
Code List
Are Focal Hepatic Lesions characterisable?
CL Item
Not applicable - no hepatic lesions (E0)
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, specify
Item
If other focal hepatic lesions, specify
text
C0577053 (UMLS CUI [1,1])
C0205234 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Gallstones or gallbladder lesions?
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Code List
Gallstones or gallbladder lesions?
CL Item
None (F0)
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 (F9)
If other gallstones or gallbladder lesions, specify
Item
If other gallstones or gallbladder lesions, specify
text
C3842395 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Biliary ductal lesions?
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
Code List
Biliary ductal lesions?
CL Item
None (G0)
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 (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, specify
Item
If other biliary ductal lesions, specify
text
C0005423 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Item
Portal/Hepatic vein abnormalities?
text
C0019155 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
Code List
Portal/Hepatic vein abnormalities?
CL Item
None (H0)
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, specify?
Item
If other portal/hepatic vein abnormalities, specify?
text
C0019155 (UMLS CUI [1])
C1704258 (UMLS CUI [2,1])
C0032718 (UMLS CUI [2,2])
C0205394 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])

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